510(k) Report

510(k) · Cleared

Cleared

Cascadia Interbody System

K160125510(k) TraditionalCleared Apr 22, 201693-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 · ODP Intervertebral Fusion Device With Bone Graft, Cervical

Cleared on Apr 22, 2016 as substantially equivalent to K150481 (K2m, Inc., 2015) and 7 other predicates after a 93-day review. Its family tree reaches back 19 generations to 1984. 1 of the 517 devices in its family, counting itself, has a Class I recall. 315 later devices descend from it.

Decided
Apr 22, 2016
Review
93 days
Class
Class II
Product code
ODP
Recalls
None
Predicates
8

Its longest line of descent runs back 19 generations to K841189 (1984). 201 ancestors in all, the oldest K792352 (1979). 315 later devices descend from it, 21 citing it directly. 1 of the 517 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 ancestors2011: 15 other ancestors2009: 18 other ancestors2008: 33 other ancestors, 1 with a Class I recall12013: 5 other ancestors2012: 8 other ancestors2010: 9 other ancestors2007: 11 other ancestors2005: 9 other ancestors2006: 5 other ancestors2004: 20 other ancestors2003: 13 other ancestors2002: 8 other ancestors2001: 10 other ancestors1999: 2 other ancestors1996: 2 other ancestors2000: 1 other ancestor1998: 1 other ancestor1980: 1 other ancestor1979: 1 other ancestor2019: 18 descendants cleared2017: 9 descendants cleared2020: 33 descendants cleared2018: 8 descendants cleared2023: 46 descendants cleared2021: 31 descendants cleared2022: 41 descendants cleared2016: 1 descendant cleared2024: 40 descendants cleared2026: 43 descendants cleared2025: 45 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) K152304 · Tritanium PL Cage · Stryker · 2015 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 7 other ancestors2 generations back: 23 other ancestors3 generations back: 49 other ancestors, 1 with a Class I recall14 generations back: 45 other ancestors5 generations back: 26 other ancestors6 generations back: 23 other ancestors7 generations back: 8 other ancestors8 generations back: 1 other ancestor 1 generation forward: 21 descendants2 generations forward: 48 descendants3 generations forward: 61 descendants4 generations forward: 66 descendants5 generations forward: 52 descendants6 generations forward: 40 descendants7 generations forward: 19 descendants8 generations forward: 6 descendants9 generations forward: 2 descendants K152304 · 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. · 1984−15−10−50+5
  1. Root · 19 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 15 generations between
  3. 3 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
  4. 2 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
  5. 1 generation backK152304 Tritanium PL CageStryker · 2015 · Recalled
  6. This deviceK160125 Cascadia Interbody SystemK2m · 2016
  7. Descendant · cites it directly · 169 of its ownK162264 Cascadia Interbody SystemK2m, Inc. · 2016
  8. Descendant · cites it directly · 145 of its ownK171140 Matrixx SystemNexxt Spine, LLC · 2017
  9. Descendant · 2 generations on · 106 of its ownK180364 HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018
  10. Descendant · cites it directly · 105 of its ownK170399 Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC · 2017
  11. Descendant · 2 generations on · 104 of its ownK183557 Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS…Titan Spine, Inc. · 2019 · Recalled
Show all 19 generations
  1. Root · 19 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 18 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 17 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 16 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 15 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 14 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
  7. 13 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
  8. 12 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
  9. 11 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
  10. 10 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
  11. 9 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
  12. 8 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
  13. 7 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
  14. 6 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
  15. 5 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
  16. 4 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
  17. 3 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
  18. 2 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
  19. 1 generation backK152304 Tritanium PL CageStryker · 2015 · Recalled
  20. This deviceK160125 Cascadia Interbody SystemK2m · 2016

Showing 5 of 315 descendants. See all descendants

Descendants cleared per year

2016: 12017: 92018: 82019: 182020: 332021: 312022: 412023: 462024: 402025: 452026: 43
2016high 46 (2023) · low 1 (2016)2026

Class I recalls in this family

  • K073202 Ardis Spacer3 generations back · 2008

Most influential descendants

Showing 5 of 315 · See all
  • K162264Cascadia Interbody SystemK2m, Inc. · 2016 · cites it directly169descendants
  • K171140Matrixx SystemNexxt Spine, LLC · 2017 · cites it directly145descendants
  • K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018 · 2 generations on106descendants
  • K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC · 2017 · cites it directly105descendants
  • K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc. · 2019 · 2 generations on104descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−19K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−18K990148Stackable Cage SystemDepuy Motech Acromed1999—
−17K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−16K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−15K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−14K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH2004—
−13K042930Spacevision Cage SystemSpine Vision, Inc.2004—
−12K062759Paramount VBR SystemInnovative Spinal Technologies, Inc.2007—
−11K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.2007—
−10K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008—
−9K094025Crescent Spinal SystemMedtronic Sofamor Danek2010—
−8K110543Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc.2011—
−7K121683Acculif TL CageCoalign Innovations, Inc.2012—
−6K123752Acculif TL and PL CageCoalign Innovations, Inc.2013—
−5K132505Acculif TL and PL CageCoalign Innovations, Inc.20133
−4K141217Acculif TL and PL CageStryker Corporation20143
−3K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK…Stryker Corporation2015—
−2K143616AccuLIF TL and PL CageStryker Corporation20154
−1K152304Tritanium PL CageStryker20151
0 (this device)K160125Cascadia Interbody SystemK2m2016—
+1K162264Cascadia Interbody SystemK2m, Inc.2016—
+1K171140Matrixx SystemNexxt Spine, LLC2017—
+2K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018—
+1K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017—
+2K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion…Titan Spine, Inc.20193

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198010
199620
199810
199920
200010
2001100
200280
2003130
2004200
200590
200650
2007110
2008331
2009180
201090
2011150
201280
201350
201480
201520

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
201790
201880
2019180
2020330
2021310
2022410
2023460
2024400
2025450
2026430
FIG. 1 — Lineage of K160125, 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 ODP device

  1. #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 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? (8)

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
…P) Intervertebral Fusion Device with Bone Graft, lumbar (21 CFR 888.3080, Product Code: MAX) Predicate Device(s) Primary Predicate:  K2M Cascadia Interbody System (K150481) Additional Predicates:  K2M Aleutian IBF Spinal System (K082698, K103169, K133614)  K2M Chesapeake Stabilization System…
K2m, Inc.20153
*K082698Aleutian Ibf System
Summary page 4
…080, Product Code: MAX) Predicate Device(s) Primary Predicate:  K2M Cascadia Interbody System (K150481) Additional Predicates:  K2M Aleutian IBF Spinal System (K082698, K103169, K133614)  K2M Chesapeake Stabilization System (K133494)  Globus Patriot (K072991)  NuVasive CoRoent (K15036…
K2m, Inc.2009—
*K103169Aleuttian
Summary page 4
…uct Code: MAX) Predicate Device(s) Primary Predicate:  K2M Cascadia Interbody System (K150481) Additional Predicates:  K2M Aleutian IBF Spinal System (K082698, K103169, K133614)  K2M Chesapeake Stabilization System (K133494)  Globus Patriot (K072991)  NuVasive CoRoent (K150362)  S…
K2m, Inc.2011—
*K133614Aleutian Ibf System
Summary page 4
…MAX) Predicate Device(s) Primary Predicate:  K2M Cascadia Interbody System (K150481) Additional Predicates:  K2M Aleutian IBF Spinal System (K082698, K103169, K133614)  K2M Chesapeake Stabilization System (K133494)  Globus Patriot (K072991)  NuVasive CoRoent (K150362)  Stryker Tr…
K2m, Inc.2014—
*K133494Chesapeake Spinal System
Summary page 4
…K2M Cascadia Interbody System (K150481) Additional Predicates:  K2M Aleutian IBF Spinal System (K082698, K103169, K133614)  K2M Chesapeake Stabilization System (K133494)  Globus Patriot (K072991)  NuVasive CoRoent (K150362)  Stryker Tritanium (K152304) Device Description The subject…
K2m, Inc.2014—
*K072991Patriot Spacers: Colonial Acdf
Summary page 4
…(K150481) Additional Predicates:  K2M Aleutian IBF Spinal System (K082698, K103169, K133614)  K2M Chesapeake Stabilization System (K133494)  Globus Patriot (K072991)  NuVasive CoRoent (K150362)  Stryker Tritanium (K152304) Device Description The subject Cascadia Interbody System is c…
Globus Medical, Inc.2008—
*K150362NuVasive CoRoent Small Interbody System
Summary page 4
…:  K2M Aleutian IBF Spinal System (K082698, K103169, K133614)  K2M Chesapeake Stabilization System (K133494)  Globus Patriot (K072991)  NuVasive CoRoent (K150362)  Stryker Tritanium (K152304) Device Description The subject Cascadia Interbody System is comprised of additively manufactu…
Nu Vasive, Incorporated2015—
*K152304Tritanium PL Cage
Summary page 4
…stem (K082698, K103169, K133614)  K2M Chesapeake Stabilization System (K133494)  Globus Patriot (K072991)  NuVasive CoRoent (K150362)  Stryker Tritanium (K152304) Device Description The subject Cascadia Interbody System is comprised of additively manufactured implants made of titanium all…
Stryker20151

Also cleared against K150481: 15 other devices →

What descends from it? (315)

See all 315

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

NumberDeviceApplicantDecidedDescendants
K162264Cascadia Interbody SystemK2m, Inc.2016169
K171140Matrixx SystemNexxt Spine, LLC2017145
K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105
K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749
K163364MOJAVE Expandable Interbody SystemK2m201725
K182477Cervical SpacerAdditive Implants, LLC201915
K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014
K170055CAPRI Corpectomy Cage SystemK2m201711
K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910
K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216

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 32 years and passes through 13 companies; a new generation was cleared every 9 months on median.
  • 26 of the 201 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K162264 (K2m, Inc., 2016) has gone furthest, with 169 descendants of its own.
  • 15 other devices also cite its predicate K150481.

How does its category compare?

All ODP devices

ODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · ODP

11in 2025

2008: 82009: 122010: 92011: 252012: 172013: 182014: 262015: 242016: 172017: 332018: 252019: 222020: 142021: 182022: 122023: 342024: 102025: 112026 (partial year): 19
2007high 34 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ODP

87in 2025

2008: 89 days median2009: 127 days median2010: 151 days median2011: 113 days median2012: 93 days median2013: 187 days median2014: 118 days median2015: 180 days median2016: 112 days median2017: 104 days median2018: 133 days median2019: 92 days median2020: 89 days median2021: 121 days median2022: 92 days median2023: 165 days median2024: 76 days median2025: 87 days median2026 (partial year): 117 days median
2007high 187 (2013) · low 76 (2024)2026

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

Recalls per year · ODP

2in 2025

2009: 12011: 12013: 12020: 12025: 2
2007high 2 (2025) · low 0 (2007)2026

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

Adverse event reports per year · ODP

57in 2025

2008: 22009: 212010: 542011: 382012: 922013: 782014: 432015: 512016: 372017: 392018: 512019: 1412020: 862021: 1612022: 502023: 362024: 552025: 57
2007high 161 (2021) · low 0 (2007)2025

MAUDE reports naming product code ODP, 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
20070—00
200888902
200912127121
20109151054
201125113138
20121793092
201318187178
201426118043
201524180051
201617112037
201733104039
201825133051
201922920141
20201489186
2021181210161
20221292050
202334165036
20241076055
20251187257
2026191170—

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 (242 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 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
  • K172941CASCADIA Interbody SystemK2m · 2018
  • K172465Idys™ TLIF 3DTi CagesClariance, Sas · 2017
  • K163595IMPIX 3D Print CagesMedicrea International SA · 20172 recalls

More from K2m

16 FDA decisions under this applicant name. See the company

  • K182182YUKON OCT Spinal SystemK2m · 2018
  • K181890Brainlab Compatible K2M Navigation InstrumentsK2m · 2018
  • K172941CASCADIA Interbody SystemK2m · 2018
  • K171556K2M Navigation InstrumentsK2m · 2018
  • K173508Everest Spinal SystemK2m · 2018

Recent decisions in ODP

The ODP category page

  • K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc. · 2026
  • K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd. · 2026
  • K2530413d Cage CervicalFims Co., Ltd. · 2026
  • K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero®…Stryker Spine · 2026
  • K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC · 2026

https://510kreport.com/device/K160125 · printed Nov 5, 2026

Cite this page

510(k) Report. “K160125: Cascadia Interbody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160125

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