510(k) Report

510(k) · Cleared

Cleared

BonOs Inject, Pedicle screw kits, Cement pusher

K202458510(k) TraditionalCleared May 18, 2021264-day reviewClass II21 CFR 888.3027

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

Osartis GmbH · LOD Bone Cement

Cleared on May 18, 2021 as substantially equivalent to K152604 (Medtronic Sofamor Danek USA, Incorporated, 2016) and 3 other predicates after a 264-day review. Its family tree reaches back 19 generations to 2004. 6 later devices descend from it.

Decided
May 18, 2021
Review
264 days
Class
Class II
Product code
LOD
Recalls
None
Predicates
4

Its longest line of descent runs back 19 generations to K040583 (2004). 179 ancestors in all, the oldest P810020 (1984). 6 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2017: 3 other ancestors2016: 2 other ancestors2009: 3 other ancestors2018: 1 other ancestor2015: 4 other ancestors2005: 16 other ancestors2014: 3 other ancestors2013: 3 other ancestors2012: 1 other ancestor2011: 3 other ancestors2010: 3 other ancestors2004: 22 other ancestors2003: 9 other ancestors2002: 8 other ancestors2000: 11 other ancestors1999: 3 other ancestors2008: 5 other ancestors2006: 9 other ancestors1984: 3 other ancestors2007: 4 other ancestors2001: 10 other ancestors1997: 5 other ancestors1996: 2 other ancestors1994: 4 other ancestors1998: 6 other ancestors1995: 7 other ancestors1988: 2 other ancestors1987: 1 other ancestor1992: 2 other ancestors1989: 1 other ancestor1986: 2 other ancestors1985: 1 other ancestor1990: 1 other ancestor2021: 1 descendant cleared2022: 1 descendant cleared2023: 2 descendants cleared2024: 1 descendant cleared2025: 1 descendant clearedReference device: K171582 · NEO Pedicle Screw System™ · Neo Medical SA · 2017×7: 7 generations cleared close together, K040583 (2004), K041118 (2004), K042025 (2004), K043151 (2005), K050809 (2005), K052187 (2005), K053101 (2006) ×2: 2 generations cleared close together, K091442 (2009), K091974 (2009) K102555 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2010×2: 2 generations cleared close together, K112473 (2011), K113174 (2011) ×2: 2 generations cleared close together, K121680 (2012), K122862 (2012) K141605 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2014K143019 · CD HORIZON Spinal System, IPC POWEREASE System · Medtronic Sofamor Danek USA, Inc. · 2015K153463 · CD HORIZON Spinal System, IPC POWEREASE System · Medtronic Sofamor Danek USA, Inc. · 2015K170679 · CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems · Medtronic Sofamor Danek · 2017K191148 · Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set · Medtronic Sofamor Danek USA, Inc. · 201919801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 5 other ancestors3 generations back: 23 other ancestors4 generations back: 27 other ancestors5 generations back: 35 other ancestors6 generations back: 34 other ancestors7 generations back: 19 other ancestors8 generations back: 7 other ancestors9 generations back: 7 other ancestors 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 2 descendants4 generations forward: 1 descendant K191148 · Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set · Medtronic Sofamor Danek USA, Inc. · 2019K170679 · CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems · Medtronic Sofamor Danek · 2017K153463 · CD HORIZON Spinal System, IPC POWEREASE System · Medtronic Sofamor Danek USA, Inc. · 2015K143019 · CD HORIZON Spinal System, IPC POWEREASE System · Medtronic Sofamor Danek USA, Inc. · 2015K141605 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2014K122862 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2012K121680 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2012K113174 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2011 · recalledK112473 · CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2011K102555 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2010K091974 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2009 · recalledK091442 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2009K053101 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2006K052187 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K050809 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2005K043151 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K042025 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2004 · recalledK041118 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek · 2004K040583 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2004−15−10−50
  1. Root · 19 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 15 generations between
  3. 3 generations backK153463 CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc. · 2015
  4. 2 generations backK170679 CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use…Medtronic Sofamor Danek · 2017
  5. 1 generation backK191148 Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™…Medtronic Sofamor Danek USA, Inc. · 2019
  6. This deviceK202458 BonOs Inject, Pedicle screw kits, Cement pusherOsartis GmbH · 2021
  7. Descendant · cites it directly · 5 of its ownK212489 BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA · 2021
  8. Descendant · 2 generations on · 3 of its ownK222256 BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA · 2022
  9. Descendant · 3 generations on · 1 of its ownK231809 Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone…Ulrich Medical USA · 2023
  10. Descendant · 4 generations on · 0 of its ownK251719 Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc. · 2025
  11. Descendant · 3 generations on · 0 of its ownK243693 NEO Pedicle Screw System™Neo Medical SA · 2024
Show all 19 generations
  1. Root · 19 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 18 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 17 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 16 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 15 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 14 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 13 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 12 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 11 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 10 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 9 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 8 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. 7 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  14. 6 generations backK122862 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  15. 5 generations backK141605 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
  16. 4 generations backK143019 CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc. · 2015
  17. 3 generations backK153463 CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc. · 2015
  18. 2 generations backK170679 CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use…Medtronic Sofamor Danek · 2017
  19. 1 generation backK191148 Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™…Medtronic Sofamor Danek USA, Inc. · 2019
  20. This deviceK202458 BonOs Inject, Pedicle screw kits, Cement pusherOsartis GmbH · 2021

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2021: 12022: 12023: 22024: 12025: 1
2021high 2 (2023) · low 0 (2026)2026

Most influential descendants

Showing 5 of 6 · See all
  • K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA · 2021 · cites it directly5descendants
  • K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA · 2022 · 2 generations on3descendants
  • K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA · 2023 · 3 generations on1descendant
  • K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc. · 2025 · 4 generations on0descendants
  • K243693NEO Pedicle Screw System™Neo Medical SA · 2024 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−19K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−18K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−17K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−16K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−15K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−14K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−13K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−12K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−11K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−10K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−9K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−8K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
−7K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012—
−6K122862CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012—
−5K141605CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014—
−4K143019CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.2015—
−3K153463CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.2015—
−2K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the…Medtronic Sofamor Danek2017—
−1K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™…Medtronic Sofamor Danek USA, Inc.2019—
0 (this device)K202458BonOs Inject, Pedicle screw kits, Cement pusherOsartis GmbH2021—
+1K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA2021—
+2K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA2022—
+3K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement…Ulrich Medical USA2023—
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.2025—
+3K243693NEO Pedicle Screw System™Neo Medical SA2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198430
198510
198620
198710
198820
198910
199010
199220
199440
199570
199620
199750
199860
199930
2000110
2001100
200280
200390
2004220
2005160
200690
200740
200850
200930
201030
201130
201210
201330
201430
201540
201620
201730
201810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202110
202210
202320
202410
202510
FIG. 1 — Lineage of K202458, 2004–2025Source: 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.

Planning a device in LOD? 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 LOD device

  1. #1 K254107 Refobacin Bone Cement R (110034355)score 11.8 · 3 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? (4)

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
*K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set
Summary page 6
…eo Pedicle Screw System™ Predicate Device - Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set (510(k) applications K152604, S.E., 01/06/2016; K170347, S.E. 04/04/2017 and K191148, S.E. 09/12/2019) Additional Predicate Device - BonOs® Inje…
Medtronic Sofamor Danek USA, Incorporated2016—
*K170347CD HORIZON™ Fenestrated Screw Set
Summary page 6
…e Device - Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set (510(k) applications K152604, S.E., 01/06/2016; K170347, S.E. 04/04/2017 and K191148, S.E. 09/12/2019) Additional Predicate Device - BonOs® Inject (510(k) application (K090460, S…
Medtronic Sofamor Danek USA2017—
*K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set
Summary page 6
…-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set (510(k) applications K152604, S.E., 01/06/2016; K170347, S.E. 04/04/2017 and K191148, S.E. 09/12/2019) Additional Predicate Device - BonOs® Inject (510(k) application (K090460, S.E.04/14/2009) Reference De…
Medtronic Sofamor Danek USA, Inc.2019—
*K090460Bonos Inject
Summary page 6
…ications K152604, S.E., 01/06/2016; K170347, S.E. 04/04/2017 and K191148, S.E. 09/12/2019) Additional Predicate Device - BonOs® Inject (510(k) application (K090460, S.E.04/14/2009) Reference Device - Neo Pedicle Screw System™ (510(k) application K171582, S.E. 09/12/2017) 4. Device…
Aap Biomaterials GmbH2009—
†K171582NEO Pedicle Screw System™Neo Medical SA2017—

Also cleared against K152604: 12 other devices →

What descends from it? (6)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 7 months on median.
  • 28 of the 179 ancestors have a recall of any class.
  • Of its descendants, K212489 (Neo Medical SA, 2021) has gone furthest, with 5 descendants of its own.
  • 12 other devices also cite its predicate K152604.

How does its category compare?

All LOD devices

LOD Bone Cement: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.

FDA decisions per year · LOD

1in 2025

2007: 22008: 12009: 32013: 22014: 12015: 42016: 12017: 32018: 22019: 42020: 32021: 42022: 32023: 22024: 12025: 12026 (partial year): 1
2007high 4 (2015) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LOD

277in 2022

2009: 103 days median2015: 138 days median2017: 96 days median2019: 90 days median2020: 139 days median2021: 95 days median2022: 277 days median
2007high 277 (2022) · low 90 (2019)2026

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

Recalls per year · LOD

2in 2022

2014: 12017: 42020: 12022: 22026 (partial year): 2
2007high 4 (2017) · low 0 (2007)2026

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

Adverse event reports per year · LOD

355in 2025

2007: 782008: 1342009: 1702010: 2912011: 4282012: 4122013: 5012014: 4652015: 5292016: 6152017: 8172018: 1,2952019: 2,3072020: 1,2942021: 7822022: 4722023: 4752024: 4922025: 355
2007high 2,307 (2019) · low 78 (2007)2025

MAUDE reports naming product code LOD, 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—078
20081—0134
200931030170
20100—0291
20110—0428
20120—0412
20132—0501
20141—1465
201541380529
20161—0615
20173964817
20182—01,295
201949002,307
2020313911,294
20214950782
202232772472
20232—0475
20241—0492
20251—0355
20261—2—

What is it indicated for?

BonOs® Inject bone cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using vertebroplasty or balloon kyphoplasty procedure. When used in conjunction with NEO Pedicle Screw System™ BonOs® Inject is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic and lumbar…

Read the full statement (273 words)

BonOs® Inject bone cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using vertebroplasty or balloon kyphoplasty procedure.

When used in conjunction with NEO Pedicle Screw System™ BonOs® Inject is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. NEO Pedicle Screws augmented with BonOs® Inject Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

The NEO Pedicle Screw System™, when used as a posterior pedicle screw system, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. The system is intended for posterior, non-cervical fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, tumor, pseudarthrosis, and/or failed previous fusion.

When used in conjunction with BonOs® Inject Cement, the NEO Pedicle Screw System™ is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. NEO Pedicle Screws augmented with BonOs® Inject Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K152604

12 other devices cite the same predicate.

  • K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd. · 2023
  • K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart · 2023
  • K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA · 2021
  • K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic · 2020
  • K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc. · 2020
  • K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc. · 2019

More from Osartis GmbH

6 FDA decisions under this applicant name. See the company

  • K240856Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer MoldsOsartis GmbH · 2024
  • K210125BonOs HV Genta, BonOs MV Genta, BonOs LV GentaOsartis GmbH · 2021
  • K210120BonOs HV, BonOs MV, BonOs LVOsartis GmbH · 2021
  • K192394Hi-Fatigue Bone CementOsartis GmbH · 2019
  • K192379Hi-Fatigue G Bone CementOsartis GmbH · 2019

Recent decisions in LOD

The LOD category page

  • K254107Refobacin Bone Cement R (110034355)Biomet France · 2026
  • K250760SPECTRUM GV Bone CementOsteoremedies, LLC · 2025
  • K241674Osteopal® VHeraeus Medical GmbH · 2024
  • K231556SPECTRUM® GV Bone CementOsteoremedies, LLC · 2023
  • K211163Bone Cement Genta, Bone Cement HV, Bone Cement LVTecres S.P.A. · 2023

https://510kreport.com/device/K202458 · printed Nov 6, 2026

Cite this page

510(k) Report. “K202458: BonOs Inject, Pedicle screw kits, Cement pusher.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202458

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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