510(k) Report

510(k) · Cleared

Cleared

CASCADIA Interbody System

K172941510(k) TraditionalCleared Feb 12, 2018139-day reviewClass II21 CFR 888.3080

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

K2m · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

Cleared on Feb 12, 2018 as substantially equivalent to K150481 (K2m, Inc., 2015) and 5 other predicates after a 139-day review. Its family tree reaches back 21 generations to 1984. 1 of the 305 devices in its family, counting itself, has a Class I recall. 52 later devices descend from it.

Decided
Feb 12, 2018
Review
139 days
Class
Class II
Product code
OVD
Recalls
None
Predicates
6

Its longest line of descent runs back 21 generations to K841189 (1984). 252 ancestors in all, the oldest K792352 (1979). 52 later devices descend from it, 8 citing it directly. 1 of the 305 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2015: 2 other ancestors2014: 8 other ancestors2013: 8 other ancestors2012: 8 other ancestors2011: 16 other ancestors2010: 10 other ancestors2009: 20 other ancestors2008: 38 other ancestors, 1 with a Class I recall12006: 8 other ancestors1997: 4 other ancestors1993: 2 other ancestors2007: 12 other ancestors2005: 13 other ancestors2004: 23 other ancestors2003: 16 other ancestors2002: 11 other ancestors1999: 3 other ancestors2001: 13 other ancestors2000: 6 other ancestors1998: 3 other ancestors1996: 3 other ancestors1995: 1 other ancestor1988: 1 other ancestor1980: 1 other ancestor1979: 1 other ancestor2023: 10 descendants cleared2024: 7 descendants cleared2022: 6 descendants cleared2019: 3 descendants cleared2018: 1 descendant cleared2025: 10 descendants cleared2021: 3 descendants cleared2020: 2 descendants cleared2026: 10 descendants clearedK841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001×2: 2 generations cleared close together, K022793 (2003), K031757 (2003) ×2: 2 generations cleared close together, K041888 (2004), K042930 (2004) K062759 · Paramount VBR System · Innovative Spinal Technologies, Inc. · 2007×2: 2 generations cleared close together, K072120 (2007), K073291 (2008) K094025 · Crescent Spinal System · Medtronic Sofamor Danek · 2010K110543 · Crescent (R) Spinal System Titanium · Medtronic Sofamor Danek USA, Inc. · 2011×2: 2 generations cleared close together, K121683 (2012), K123752 (2013) K132505 · Acculif TL and PL Cage · Coalign Innovations, Inc. · 2013 · recalled×3: 3 generations cleared close together, K141217 (2014), K143163 (2015), K143616 (2015) ×3: 3 generations cleared close together, K152304 (2015), K160125 (2016), K162264 (2016) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 17 other ancestors3 generations back: 31 other ancestors, 1 with a Class I recall14 generations back: 51 other ancestors5 generations back: 46 other ancestors6 generations back: 34 other ancestors7 generations back: 23 other ancestors8 generations back: 20 other ancestors9 generations back: 4 other ancestors 1 generation forward: 8 descendants2 generations forward: 11 descendants3 generations forward: 11 descendants4 generations forward: 9 descendants5 generations forward: 9 descendants6 generations forward: 3 descendants7 generations forward: 1 descendant K162264 · Cascadia Interbody System · K2m, Inc. · 2016K160125 · Cascadia Interbody System · K2m · 2016K152304 · Tritanium PL Cage · Stryker · 2015 · recalledK143616 · AccuLIF TL and PL Cage · Stryker Corporation · 2015 · recalledK143163 · AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage System · Stryker Corporation · 2015K141217 · Acculif TL and PL Cage · Stryker Corporation · 2014 · recalledK132505 · Acculif TL and PL Cage · Coalign Innovations, Inc. · 2013 · recalledK123752 · Acculif TL and PL Cage · Coalign Innovations, Inc. · 2013K121683 · Acculif TL Cage · Coalign Innovations, Inc. · 2012K110543 · Crescent (R) Spinal System Titanium · Medtronic Sofamor Danek USA, Inc. · 2011K094025 · Crescent Spinal System · Medtronic Sofamor Danek · 2010K073291 · Capstone Spinal System · Medtronic Sofamor Danek USA, Inc. · 2008K072120 · Paramount Intervertebral Body Fusion Device · Innovative Spinal Technologies, Inc. · 2007K062759 · Paramount VBR System · Innovative Spinal Technologies, Inc. · 2007K042930 · Spacevision Cage System · Spine Vision, Inc. · 2004K041888 · Curved Peek Tetris Spinal Implant · Signus Medizintechnik GmbH · 2004K031757 · Peek Tetris Spinal Implant · Signus Medical, LLC · 2003K022793 · Tetris Spinal Implant · Signus Medical, LLC · 2003K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984−20−15−10−50+5
  1. Root · 21 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 17 generations between
  3. 3 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
  4. 2 generations backK160125 Cascadia Interbody SystemK2m · 2016
  5. 1 generation backK162264 Cascadia Interbody SystemK2m, Inc. · 2016
  6. This deviceK172941 CASCADIA Interbody SystemK2m · 2018
  7. Descendant · cites it directly · 24 of its ownK181347 Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC · 2018
  8. Descendant · cites it directly · 13 of its ownK191354 Ti3Z Cervical Interbody SystemZavation Medical Products, LLC · 2019
  9. Descendant · 2 generations on · 12 of its ownK213935 PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems · 2022
  10. Descendant · 2 generations on · 9 of its ownK202398 Ti3Z Cervical Interbody SystemZavation Medical Products, LLC · 2021
  11. Descendant · 2 generations on · 9 of its ownK202305 Zavation IBF SystemZavation Medical Products, LLC · 2020
Show all 21 generations
  1. Root · 21 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 20 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 19 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 18 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 17 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 16 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
  7. 15 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
  8. 14 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
  9. 13 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
  10. 12 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
  11. 11 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
  12. 10 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
  13. 9 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
  14. 8 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
  15. 7 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
  16. 6 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
  17. 5 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
  18. 4 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
  19. 3 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
  20. 2 generations backK160125 Cascadia Interbody SystemK2m · 2016
  21. 1 generation backK162264 Cascadia Interbody SystemK2m, Inc. · 2016
  22. This deviceK172941 CASCADIA Interbody SystemK2m · 2018

Showing 5 of 52 descendants. See all descendants

Descendants cleared per year

2018: 12019: 32020: 22021: 32022: 62023: 102024: 72025: 102026: 10
2018high 10 (2023) · low 1 (2018)2026

Class I recalls in this family

  • K073202 Ardis Spacer3 generations back · 2008

Most influential descendants

Showing 5 of 52 · See all
  • K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC · 2018 · cites it directly24descendants
  • K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC · 2019 · cites it directly13descendants
  • K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems · 2022 · 2 generations on12descendants
  • K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC · 2021 · 2 generations on9descendants
  • K202305Zavation IBF SystemZavation Medical Products, LLC · 2020 · 2 generations on9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−21K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−20K990148Stackable Cage SystemDepuy Motech Acromed1999—
−19K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−18K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−17K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−16K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH2004—
−15K042930Spacevision Cage SystemSpine Vision, Inc.2004—
−14K062759Paramount VBR SystemInnovative Spinal Technologies, Inc.2007—
−13K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.2007—
−12K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008—
−11K094025Crescent Spinal SystemMedtronic Sofamor Danek2010—
−10K110543Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc.2011—
−9K121683Acculif TL CageCoalign Innovations, Inc.2012—
−8K123752Acculif TL and PL CageCoalign Innovations, Inc.2013—
−7K132505Acculif TL and PL CageCoalign Innovations, Inc.20133
−6K141217Acculif TL and PL CageStryker Corporation20143
−5K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK…Stryker Corporation2015—
−4K143616AccuLIF TL and PL CageStryker Corporation20154
−3K152304Tritanium PL CageStryker20151
−2K160125Cascadia Interbody SystemK2m2016—
−1K162264Cascadia Interbody SystemK2m, Inc.2016—
0 (this device)K172941CASCADIA Interbody SystemK2m2018—
+1K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC2018—
+1K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC2019—
+2K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems2022—
+2K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC2021—
+2K202305Zavation IBF SystemZavation Medical Products, LLC2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198010
198810
199320
199510
199630
199740
199830
199930
200060
2001130
2002110
2003160
2004230
2005130
200680
2007120
2008381
2009200
2010100
2011160
201280
201380
201480
201520

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
201930
202020
202130
202260
2023100
202470
2025100
2026100
FIG. 1 — Lineage of K172941, 1984–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new OVD device

  1. #1 K222009 aprevo® anterior lumbar interbody fusion…score 26.0 · 23 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (6)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K150481Cascadia Interbody System
Summary page 4
…D) Intervertebral Fusion Device with Bone Graft, cervical 21 CFR 888.3080, Product Code: ODP) Predicate Device(s) Primary Predicate:  K2M CASCADIA Interbody System (K150481) Additional Predicates:  K2M CASCADIA Interbody System (K162264)  K2M CAYMAN Plate System (K131533)  Zimmer-Biomet (K…
K2m, Inc.20153
*K162264Cascadia Interbody System
Summary page 4
….3080, Product Code: ODP) Predicate Device(s) Primary Predicate:  K2M CASCADIA Interbody System (K150481) Additional Predicates:  K2M CASCADIA Interbody System (K162264)  K2M CAYMAN Plate System (K131533)  Zimmer-Biomet (K123767, K131547)  Aleutian Interbody System (K133614) Device D…
K2m, Inc.2016—
*K131533Cayman MI Plate System
Summary page 4
…vice(s) Primary Predicate:  K2M CASCADIA Interbody System (K150481) Additional Predicates:  K2M CASCADIA Interbody System (K162264)  K2M CAYMAN Plate System (K131533)  Zimmer-Biomet (K123767, K131547)  Aleutian Interbody System (K133614) Device Description The CASCADIA implants consis…
K2m, Inc.2013—
*K123767Lanx Fusion System- SA
Summary page 4
… K2M CASCADIA Interbody System (K150481) Additional Predicates:  K2M CASCADIA Interbody System (K162264)  K2M CAYMAN Plate System (K131533)  Zimmer-Biomet (K123767, K131547)  Aleutian Interbody System (K133614) Device Description The CASCADIA implants consist of hollow tube structures a…
Lanx, Inc.20134
*K131547Lanx Fusion System
Summary page 4
…SCADIA Interbody System (K150481) Additional Predicates:  K2M CASCADIA Interbody System (K162264)  K2M CAYMAN Plate System (K131533)  Zimmer-Biomet (K123767, K131547)  Aleutian Interbody System (K133614) Device Description The CASCADIA implants consist of hollow tube structures additively…
Lanx, Inc.20131
*K133614Aleutian Ibf System
Summary page 4
…nal Predicates:  K2M CASCADIA Interbody System (K162264)  K2M CAYMAN Plate System (K131533)  Zimmer-Biomet (K123767, K131547)  Aleutian Interbody System (K133614) Device Description The CASCADIA implants consist of hollow tube structures additively manufactured from titanium alloy. The de…
K2m, Inc.2014—

Also cleared against K150481: 15 other devices →

What descends from it? (52)

See all 52

8 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824
K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913
K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193
K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251
K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241
K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231
K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221
K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 3 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 34 years and passes through 14 companies; a new generation was cleared every 9 months on median.
  • 33 of the 252 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K181347 (Osseus Fusion Systems, LLC, 2018) has gone furthest, with 24 descendants of its own.
  • 15 other devices also cite its predicate K150481.

How does its category compare?

All OVD devices

OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · OVD

10in 2025

2007: 22008: 82009: 32010: 82011: 92012: 102013: 112014: 142015: 122016: 132017: 122018: 142019: 122020: 142021: 72022: 142023: 122024: 122025: 102026 (partial year): 8
2007high 14 (2014) · low 2 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OVD

100in 2025

2008: 84 days median2009: 152 days median2010: 117 days median2011: 167 days median2012: 78 days median2013: 137 days median2014: 139 days median2015: 166 days median2016: 127 days median2017: 127 days median2018: 126 days median2019: 91 days median2020: 91 days median2021: 108 days median2022: 133 days median2023: 92 days median2024: 110 days median2025: 100 days median2026 (partial year): 93 days median
2007high 167 (2011) · low 78 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OVD

1in 2025

2013: 42016: 12021: 12022: 12025: 12026 (partial year): 1
2007high 4 (2013) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OVD

50in 2025

2009: 22010: 22011: 62012: 162013: 172014: 352015: 432016: 552017: 722018: 1122019: 1712020: 2032021: 2212022: 742023: 672024: 922025: 50
2007high 221 (2021) · low 0 (2007)2025

MAUDE reports naming product code OVD, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—00
200888400
2009315202
2010811702
2011916706
20121078016
201311137417
201414139035
201512166043
201613127155
201712127072
2018141260112
201912910171
202014910203
202171081221
202214133174
20231292067
202412110092
202510100150
20268931—

What is it indicated for?

The CASCADIA lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD…

Read the full statement (290 words)

The CASCADIA lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. Additionally, the CASCADIA lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. CASCADIA lumbar implants are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.

The CASCADIA hyperlordotic lateral lumbar implants (≥22°), are intended for levels L2-L5 and are to be used with CAYMAN United plates in addition to posterior supplemental fixation. The CASCADIA non-hyperlordotic lateral lumbar implants may optionally be used with CAYMAN United plates, in addition to supplemental spinal fixation systems.

The CASCADIA cervical implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with cervical disc disease (DDD) at one level or two contiguous levels from C2 to T1. These patients should be skeletally mature and have had six weeks of non-operative treatment. The CASCADIA cervical implants are also to be used with supplemental fixation; the hyperlordotic CASCADIA cervical implants (i.e., ≥ 10°) are required to be used with an anterior cervical plate as the form of supplemental fixation.

Indications for use as stated in the FDA summary.

Also cleared against K150481

15 other devices cite the same predicate.

  • K180230NEST Interbody SystemPaonan Biotech Co., Ltd. · 2019
  • K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC · 2018
  • K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc. · 2018
  • K172465Idys™ TLIF 3DTi CagesClariance, Sas · 2017
  • K163595IMPIX 3D Print CagesMedicrea International SA · 20172 recalls
  • K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies · 2017

More from K2m

16 FDA decisions under this applicant name. See the company

  • K182182YUKON OCT Spinal SystemK2m · 2018
  • K181890Brainlab Compatible K2M Navigation InstrumentsK2m · 2018
  • K171556K2M Navigation InstrumentsK2m · 2018
  • K173508Everest Spinal SystemK2m · 2018
  • K171704CAPRI Corpectomy Cage SystemK2m · 2017

Recent decisions in OVD

The OVD category page

  • K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium…INNO Holdings Inc. DBA Innovasis · 2026
  • K261408SABER-XA SystemElevation Spine · 2026
  • K261809Interwedge® Standalone LateralFoundation Surgical Group · 2026
  • K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemKyocera Medical Technologies, Inc. · 2026
  • K260810Anteralign LS coverplateTyber Medical, LLC · 2026

https://510kreport.com/device/K172941 · printed Nov 6, 2026

Cite this page

510(k) Report. “K172941: CASCADIA Interbody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172941

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026