510(k) Report

510(k) · Cleared

Cleared

NuVasive® Modulus-C Interbody System

K172676510(k) TraditionalCleared Dec 14, 2017100-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

Nu Vasive, Incorporated · ODP Intervertebral Fusion Device With Bone Graft, Cervical

Cleared on Dec 14, 2017 as substantially equivalent to K163491 (Nu Vasive, Incorporated, 2017) and 5 other predicates after a 100-day review. Its family tree reaches back 20 generations to 1984. 1 of the 377 devices in its family, counting itself, has a Class I recall. 125 later devices descend from it.

Decided
Dec 14, 2017
Review
100 days
Class
Class II
Product code
ODP
Recalls
None
Predicates
6

Its longest line of descent runs back 20 generations to K841189 (1984). 251 ancestors in all. 125 later devices descend from it, 7 citing it directly. 1 of the 377 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2017: 2 other ancestors2014: 13 other ancestors2013: 14 other ancestors2008: 37 other ancestors, 1 with a Class I recall12016: 3 other ancestors2015: 7 other ancestors2011: 20 other ancestors2009: 21 other ancestors2001: 10 other ancestors2012: 10 other ancestors2007: 14 other ancestors2005: 12 other ancestors2010: 13 other ancestors2006: 7 other ancestors2004: 19 other ancestors2003: 14 other ancestors2002: 9 other ancestors1999: 2 other ancestors1996: 2 other ancestors2000: 2 other ancestors2021: 10 descendants cleared2019: 6 descendants cleared2022: 13 descendants cleared2023: 15 descendants cleared2024: 25 descendants cleared2020: 5 descendants cleared2026: 26 descendants cleared2025: 25 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. · 2007K072120 · Paramount Intervertebral Body Fusion Device · Innovative Spinal Technologies, Inc. · 2007K073291 · Capstone Spinal System · Medtronic Sofamor Danek USA, Inc. · 2008K094025 · Crescent Spinal System · Medtronic Sofamor Danek · 2010K110543 · Crescent (R) Spinal System Titanium · Medtronic Sofamor Danek USA, Inc. · 2011K121683 · Acculif TL Cage · Coalign Innovations, Inc. · 2012K123752 · Acculif TL and PL Cage · Coalign Innovations, Inc. · 2013K132505 · Acculif TL and PL Cage · Coalign Innovations, Inc. · 2013 · recalledK141217 · Acculif TL and PL Cage · Stryker Corporation · 2014 · 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 · 2015×3: 3 generations cleared close together, K153782 (2016), K160916 (2016), K162138 (2016) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 10 other ancestors3 generations back: 35 other ancestors4 generations back: 71 other ancestors, 1 with a Class I recall15 generations back: 47 other ancestors6 generations back: 33 other ancestors7 generations back: 23 other ancestors8 generations back: 7 other ancestors 1 generation forward: 7 descendants2 generations forward: 19 descendants3 generations forward: 19 descendants4 generations forward: 16 descendants5 generations forward: 16 descendants6 generations forward: 23 descendants7 generations forward: 16 descendants8 generations forward: 8 descendants9 generations forward: 1 descendant K162138 · NuVasive CoRoent Small Ti-C System · Nu Vasive, Incorporated · 2016K160916 · CoRoent® Ti-C System · Nu Vasive, Incorporated · 2016K153782 · NuVasive® Lumbar Interbody Implants · Nu Vasive, Incorporated · 2016K143163 · 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 · 20 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 16 generations between
  3. 3 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
  4. 2 generations backK160916 CoRoent® Ti-C SystemNu Vasive, Incorporated · 2016
  5. 1 generation backK162138 NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated · 2016
  6. This deviceK172676 NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated · 2017
  7. Descendant · cites it directly · 104 of its ownK183557 Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS…Titan Spine, Inc. · 2019 · Recalled
  8. Descendant · 2 generations on · 102 of its ownK192018 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc. · 2019 · Recalled
  9. Descendant · 3 generations on · 81 of its ownK191581 Endoskeleton TL Interbody Fusion Device, Endoskeleton TL…Titan Spine, Inc. · 2020
  10. Descendant · 4 generations on · 79 of its ownK201267 Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek · 2020
  11. Descendant · 3 generations on · 75 of its ownK211258 Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System…Medtronic Sofamor Danek USA, Inc. · 2021
Show all 20 generations
  1. Root · 20 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 19 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 18 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 17 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 16 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 15 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
  7. 14 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
  8. 13 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
  9. 12 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
  10. 11 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
  11. 10 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
  12. 9 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
  13. 8 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
  14. 7 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
  15. 6 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
  16. 5 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
  17. 4 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
  18. 3 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
  19. 2 generations backK160916 CoRoent® Ti-C SystemNu Vasive, Incorporated · 2016
  20. 1 generation backK162138 NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated · 2016
  21. This deviceK172676 NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated · 2017

Showing 5 of 125 descendants. See all descendants

Descendants cleared per year

2019: 62020: 52021: 102022: 132023: 152024: 252025: 252026: 26
2019high 26 (2026) · low 5 (2020)2026

Class I recalls in this family

  • K073202 Ardis Spacer4 generations back · 2008

Most influential descendants

Showing 5 of 125 · See all
  • K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc. · 2019 · cites it directly104descendants
  • K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc. · 2019 · 2 generations on102descendants
  • K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc. · 2020 · 3 generations on81descendants
  • K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek · 2020 · 4 generations on79descendants
  • K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc. · 2021 · 3 generations on75descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−20K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−19K990148Stackable Cage SystemDepuy Motech Acromed1999—
−18K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−17K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−16K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−15K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH2004—
−14K042930Spacevision Cage SystemSpine Vision, Inc.2004—
−13K062759Paramount VBR SystemInnovative Spinal Technologies, Inc.2007—
−12K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.2007—
−11K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008—
−10K094025Crescent Spinal SystemMedtronic Sofamor Danek2010—
−9K110543Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc.2011—
−8K121683Acculif TL CageCoalign Innovations, Inc.2012—
−7K123752Acculif TL and PL CageCoalign Innovations, Inc.2013—
−6K132505Acculif TL and PL CageCoalign Innovations, Inc.20133
−5K141217Acculif TL and PL CageStryker Corporation20143
−4K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK…Stryker Corporation2015—
−3K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016—
−2K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016—
−1K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016—
0 (this device)K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017—
+1K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion…Titan Spine, Inc.20193
+2K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc.20194
+3K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic…Titan Spine, Inc.2020—
+4K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek2020—
+3K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System…Medtronic Sofamor Danek USA, Inc.2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199620
199920
200020
2001100
200290
2003140
2004190
2005120
200670
2007140
2008371
2009210
2010130
2011200
2012100
2013140
2014130
201570
201630
201720

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201960
202050
2021100
2022130
2023150
2024250
2025250
2026260
FIG. 1 — Lineage of K172676, 1984–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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? (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
*K163491NuVasive CoRoent Small Interbody System
Summary page 4
…The subject NuVasive Modulus-C Interbody System is substantially equivalent to the primary predicate device NuVasive CoRoent® Small Interbody System cleared in K163491. Additional predicates include NuVasive Modulus XLIF Interbody System (K163230), CoRoent Small Interbody System (K14000…
Nu Vasive, Incorporated2017—
*K163230NuVasive Modulus XLIF Interbody System
Summary page 4
…the primary predicate device NuVasive CoRoent® Small Interbody System cleared in K163491. Additional predicates include NuVasive Modulus XLIF Interbody System (K163230), CoRoent Small Interbody System (K140003), NuVasive CoRoent System (K081611), NuVasive CoRoent Small Ti-C System (K162…
Nu Vasive, Incorporated2017—
*K140003Coroent Small Interbody System
Summary page 4
…ent® Small Interbody System cleared in K163491. Additional predicates include NuVasive Modulus XLIF Interbody System (K163230), CoRoent Small Interbody System (K140003), NuVasive CoRoent System (K081611), NuVasive CoRoent Small Ti-C System (K162138) and VariLift® Cervical Interbody Fusion…
Nuvasive, Inc.2014—
*K081611Nuvasive Coroent System
Summary page 4
…in K163491. Additional predicates include NuVasive Modulus XLIF Interbody System (K163230), CoRoent Small Interbody System (K140003), NuVasive CoRoent System (K081611), NuVasive CoRoent Small Ti-C System (K162138) and VariLift® Cervical Interbody Fusion Device (K120603). D. Device D…
Nuvasive, Inc.2008—
*K162138NuVasive CoRoent Small Ti-C System
Summary page 4
…asive Modulus XLIF Interbody System (K163230), CoRoent Small Interbody System (K140003), NuVasive CoRoent System (K081611), NuVasive CoRoent Small Ti-C System (K162138) and VariLift® Cervical Interbody Fusion Device (K120603). D. Device Description The subject NuVasive Modulus-C Inte…
Nu Vasive, Incorporated2016—
*K120603Varilift -C
Summary page 4
…all Interbody System (K140003), NuVasive CoRoent System (K081611), NuVasive CoRoent Small Ti-C System (K162138) and VariLift® Cervical Interbody Fusion Device (K120603). D. Device Description The subject NuVasive Modulus-C Interbody System are interbody implants manufactured from tit…
Wenzel Spine2013—

Also cleared against K163491: 12 other devices →

What descends from it? (125)

See all 125

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

NumberDeviceApplicantDecidedDescendants
K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.2019104
K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916
K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115
K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213
K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311
K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217
K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243

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 · 4 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 33 years and passes through 12 companies; a new generation was cleared every 11 months on median.
  • 30 of the 251 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K183557 (Titan Spine, Inc., 2019) has gone furthest, with 104 descendants of its own.
  • 12 other devices also cite its predicate K163491.

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. 2017, 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 NuVasive Modulus-C Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Modulus-C Interbody System is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical and/or corticocancellous bone graft to facilitate fusion.

Indications for use as stated in the FDA summary.

Also cleared against K163491

12 other devices cite the same predicate.

  • K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent…Nu Vasive, Incorporated · 2023
  • K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd. · 2022
  • K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion SystemMeditech Spine, LLC · 2020
  • K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated · 2019
  • K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC · 2019
  • K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc. · 2018

More from Nu Vasive, Incorporated

112 FDA decisions under this applicant name. See the company

  • K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent…Nu Vasive, Incorporated · 2023
  • K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated · 2023
  • K230989Rod Registration FrameNu Vasive, Incorporated · 2023
  • K223181NuVasive Reline SystemNu Vasive, Incorporated · 2023
  • K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated · 2022

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/K172676 · printed Nov 6, 2026

Cite this page

510(k) Report. “K172676: NuVasive® Modulus-C 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/K172676

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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