510(k) Report

510(k) · Cleared

Cleared

ROMEO® 2 Posterior Osteosynthesis System

K172101510(k) TraditionalCleared Sep 26, 201776-day reviewClass II21 CFR 888.3070

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

Spineart · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Sep 26, 2017 as substantially equivalent to K081165 (Spineart, 2008) and 11 other predicates after a 76-day review. Its family tree reaches back 18 generations to 2001. 1 of the 399 devices in its family, counting itself, has a Class I recall. 9 later devices descend from it.

Decided
Sep 26, 2017
Review
76 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
12

Its longest line of descent runs back 18 generations to K003155 (2001). 389 ancestors in all, the oldest K781443 (1978). 9 later devices descend from it, 5 citing it directly. 1 of the 399 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2015: 1 other ancestor2014: 4 other ancestors2013: 7 other ancestors2011: 16 other ancestors2010: 24 other ancestors, 1 with a Class I recall12009: 24 other ancestors2008: 24 other ancestors2012: 8 other ancestors2007: 17 other ancestors2006: 27 other ancestors2005: 36 other ancestors2003: 21 other ancestors2001: 24 other ancestors1998: 14 other ancestors2002: 18 other ancestors2000: 23 other ancestors1999: 10 other ancestors1997: 7 other ancestors1996: 6 other ancestors1995: 7 other ancestors1991: 1 other ancestor2004: 36 other ancestors1994: 2 other ancestors1993: 4 other ancestors1992: 5 other ancestors1990: 2 other ancestors1978: 1 other ancestor1985: 1 other ancestor1984: 1 other ancestor2018: 1 descendant cleared2022: 1 descendant cleared2023: 2 descendants cleared2020: 2 descendants cleared2024: 1 descendant cleared2021: 1 descendant cleared2026: 1 descendant clearedK003155 · Vertebral Body Replacement · Osteotech, Inc. · 2001K012254 · VBR · Osteotech, Inc. · 2001×3: 3 generations cleared close together, K021791 (2002), K023570 (2002), K030601 (2003) ×3: 3 generations cleared close together, K040536 (2004), K041556 (2004), K043561 (2004) ×3: 3 generations cleared close together, K060719 (2006), K061938 (2006), K062427 (2006) K070742 · Modification to Vertex Reconstruction System · Medtronic Sofamor Danek · 2007K110522 · Vertex Reconstruction System, Vertex Select Reconstruction System · Medtronic Sofamor Danek USA, Inc. · 2011K113593 · Nextgen Altius Oct System · Biomet Spine (Aka Ebi, LLC) · 2012×3: 3 generations cleared close together, K123549 (2013), K131615 (2013), K133746 (2014) K143248 · Reform Pedicle Screw System · Precision Spine, Inc. · 201419801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 11 other ancestors2 generations back: 37 other ancestors3 generations back: 56 other ancestors4 generations back: 90 other ancestors, 1 with a Class I recall15 generations back: 93 other ancestors6 generations back: 49 other ancestors7 generations back: 20 other ancestors8 generations back: 12 other ancestors9 generations back: 1 other ancestor10 generations back: 2 other ancestors 1 generation forward: 5 descendants2 generations forward: 4 descendants K143248 · Reform Pedicle Screw System · Precision Spine, Inc. · 2014K133746 · Polaris Spinal System · Biomet Spine (Aka Ebi, LLC) · 2014 · recalledK131615 · Polaris Spinal System · Biomet Spine (Aka Ebi, LLC) · 2013K123549 · Polaris Spinal System - Ballista II Percutaneous Screw Placement System · Biomet Spine (Aka Ebi, LLC) · 2013 · recalledK113593 · Nextgen Altius Oct System · Biomet Spine (Aka Ebi, LLC) · 2012K110522 · Vertex Reconstruction System, Vertex Select Reconstruction System · Medtronic Sofamor Danek USA, Inc. · 2011K070742 · Modification to Vertex Reconstruction System · Medtronic Sofamor Danek · 2007K062427 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2006K061938 · Verte-Stack Spinal System · Medtronic Sofamor Danek, Inc. · 2006K060719 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2006K043561 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2004K041556 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2004K040536 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2004K030601 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2003K023570 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2002K021791 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2002K012254 · VBR · Osteotech, Inc. · 2001K003155 · Vertebral Body Replacement · Osteotech, Inc. · 2001−15−10−50
  1. Root · 18 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 14 generations between
  3. 3 generations backK131615 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013
  4. 2 generations backK133746 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · Recalled
  5. 1 generation backK143248 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2014
  6. This deviceK172101 ROMEO® 2 Posterior Osteosynthesis SystemSpineart · 2017
  7. Descendant · cites it directly · 7 of its ownK193396 PERLA® TL posterior osteosynthesis systemSpineart · 2020 · Recalled
  8. Descendant · cites it directly · 4 of its ownK203222 PERLA TL Posterior Osteosynthesis SystemSpineart · 2020
  9. Descendant · 2 generations on · 3 of its ownK203506 PERLA® TL posterior osteosynthesis systemSpineart · 2021 · Recalled
  10. Descendant · cites it directly · 2 of its ownK213470 PERLA® TL Posterior Osteosynthesis SystemSpineart · 2022
  11. Descendant · cites it directly · 1 of its ownK231069 PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA · 2023
Show all 18 generations
  1. Root · 18 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 17 generations backK012254 VBROsteotech, Inc. · 2001
  3. 16 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  4. 15 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  5. 14 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
  6. 13 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  7. 12 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  8. 11 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  9. 10 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
  10. 9 generations backK061938 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2006
  11. 8 generations backK062427 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
  12. 7 generations backK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
  13. 6 generations backK110522 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011
  14. 5 generations backK113593 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012
  15. 4 generations backK123549 Polaris Spinal System - Ballista II Percutaneous Screw Placement…Biomet Spine (Aka Ebi, LLC) · 2013 · Recalled
  16. 3 generations backK131615 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013
  17. 2 generations backK133746 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · Recalled
  18. 1 generation backK143248 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2014
  19. This deviceK172101 ROMEO® 2 Posterior Osteosynthesis SystemSpineart · 2017

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2018: 12020: 22021: 12022: 12023: 22024: 12026: 1
2018high 2 (2020) · low 0 (2019)2026

Class I recalls in this family

  • K100952 Modification to Synthes Matrix System4 generations back · 2010

Most influential descendants

Showing 5 of 9 · See all
  • K193396PERLA® TL posterior osteosynthesis systemSpineart · 2020 · cites it directly7descendants
  • K203222PERLA TL Posterior Osteosynthesis SystemSpineart · 2020 · cites it directly4descendants
  • K203506PERLA® TL posterior osteosynthesis systemSpineart · 2021 · 2 generations on3descendants
  • K213470PERLA® TL Posterior Osteosynthesis SystemSpineart · 2022 · cites it directly2descendants
  • K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA · 2023 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−18K003155Vertebral Body ReplacementOsteotech, Inc.2001—
−17K012254VBROsteotech, Inc.2001—
−16K021791Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−15K023570Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−14K030601Verte-Stack Spinal SystemMedtronic Sofamor Danek2003—
−13K040536Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−12K041556Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−11K043561Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−10K060719Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2006—
−9K061938Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc.2006—
−8K062427Verte-Stack Spinal SystemMedtronic Sofamor Danek2006—
−7K070742Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2007—
−6K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2011—
−5K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012—
−4K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)20132
−3K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2013—
−2K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)20141
−1K143248Reform Pedicle Screw SystemPrecision Spine, Inc.2014—
0 (this device)K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart2017—
+1K193396PERLA® TL posterior osteosynthesis systemSpineart20202
+1K203222PERLA TL Posterior Osteosynthesis SystemSpineart2020—
+2K203506PERLA® TL posterior osteosynthesis systemSpineart20212
+1K213470PERLA® TL Posterior Osteosynthesis SystemSpineart2022—
+1K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198410
198510
199020
199110
199250
199340
199420
199570
199660
199770
1998140
1999100
2000230
2001240
2002180
2003210
2004360
2005360
2006270
2007170
2008240
2009240
2010241
2011160
201280
201370
201440
201510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
202020
202110
202210
202320
202410
202610
FIG. 1 — Lineage of K172101, 2001–2026Source: 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 NKB device

  1. #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 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? (12)

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
*K081165Ellipse Lumbar Posterior Osteosynthesis System
Summary page 4
…additional sizes and a new connector design to the ROMEO® 2 Posterior Ksteosynthesis Basis for submission ^ystem cleared under K081165, K093170, K093936, K101678, K111127, K112108, K130267, K140948 and K151695 SPINEART…
Spineart2008—
*K093170Romeo Posterior Osteosynthesis System
Summary page 4
…additional sizes and a new connector design to the ROMEO® 2 Posterior Ksteosynthesis Basis for submission ^ystem cleared under K081165, K093170, K093936, K101678, K111127, K112108, K130267, K140948 and K151695 SPINEART…
Spineart2009—
*K093936Romeo Posterior Osteosynthesis System
Summary page 4
…additional sizes and a new connector design to the ROMEO® 2 Posterior Ksteosynthesis Basis for submission ^ystem cleared under K081165, K093170, K093936, K101678, K111127, K112108, K130267, K140948 and K151695 SPINEART…
Spineart2010—
*K101678Romeo Posterior Osteosynthesis System
Summary page 4
…nal sizes and a new connector design to the ROMEO® 2 Posterior Ksteosynthesis Basis for submission ^ystem cleared under K081165, K093170, K093936, K101678, K111127, K112108, K130267, K140948 and K151695 SPINEART 3 C…
Spineart2010—
*K111127Romeo Posterior Osteosynthesis System
Summary page 4
…and a new connector design to the ROMEO® 2 Posterior Ksteosynthesis Basis for submission ^ystem cleared under K081165, K093170, K093936, K101678, K111127, K112108, K130267, K140948 and K151695 SPINEART 3 Chemin du…
Spineart2011—
*K112108Romeo Posterior Osteosynthesis System
Summary page 4
…w connector design to the ROMEO® 2 Posterior Ksteosynthesis Basis for submission ^ystem cleared under K081165, K093170, K093936, K101678, K111127, K112108, K130267, K140948 and K151695 SPINEART 3 Chemin du Pré Fleur…
Spineart2011—
*K130267Romeo Posterior Osteosynthesis System
Summary page 4
…or design to the ROMEO® 2 Posterior Ksteosynthesis Basis for submission ^ystem cleared under K081165, K093170, K093936, K101678, K111127, K112108, K130267, K140948 and K151695 SPINEART 3 Chemin du Pré Fleuri Submitt…
Spineart2013—
*K140948Romeo Posterior Osteosynthesis System
Summary page 4
…ior Ksteosynthesis Basis for submission ^ystem cleared under K081165, K093170, K093936, K101678, K111127, K112108, K130267, K140948 and K151695 SPINEART 3 Chemin du Pré Fleuri Submitted by 122…
Spineart2014—
*K151695Romeo posterior osteosynthesis system
Summary page 4
…thesis Basis for submission ^ystem cleared under K081165, K093170, K093936, K101678, K111127, K112108, K130267, K140948 and K151695 SPINEART 3 Chemin du Pré Fleuri Submitted by 1228 PLAN LES O…
Spineart2015—
*K143248Reform Pedicle Screw System
Summary page 4
…3170, K093936, predicate devices K101678, K111127, K112108, K130267, K140948, K151695) manufactured by Spineart, Reform Pedicle Screw System (K143248) manufactured by Precision Spine, Inc and Xia (K142381) / Xia - Mantis (K133188) manufactured by Stryker S…
Precision Spine, Inc.2014—
*K142381Xia 3 Spinal System
Summary page 4
…948, K151695) manufactured by Spineart, Reform Pedicle Screw System (K143248) manufactured by Precision Spine, Inc and Xia (K142381) / Xia - Mantis (K133188) manufactured by Stryker Spine The ROMEO®2 WŽƐƚĞƌŝŽƌKƐƚĞŽƐLJŶƚŚĞƐŝƐ^LJƐƚĞŵ is int…
Stryker Corp.2014—
*K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…
Summary page 4
…d by Spineart, Reform Pedicle Screw System (K143248) manufactured by Precision Spine, Inc and Xia (K142381) / Xia - Mantis (K133188) manufactured by Stryker Spine The ROMEO®2 WŽƐƚĞƌŝŽƌKƐƚĞŽƐLJŶƚŚĞƐŝƐ^LJƐƚĞŵ is intended to provide immobili…
Stryker Spine2013—

Also cleared against K081165: 11 other devices →

What descends from it? (9)

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

NumberDeviceApplicantDecidedDescendants
K193396PERLA® TL posterior osteosynthesis systemSpineart20207
K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204
K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222
K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231
K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180

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.

  • K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 4 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 16 years and passes through 7 companies; a new generation was cleared every 9 months on median.
  • 38 of the 389 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K193396 (Spineart, 2020) has gone furthest, with 7 descendants of its own.
  • 11 other devices also cite its predicate K081165.

How does its category compare?

All NKB devices

NKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · NKB

24in 2025

2007: 382008: 362009: 442010: 372011: 482012: 602013: 352014: 462015: 552016: 502017: 632018: 562019: 392020: 482021: 322022: 342023: 442024: 392025: 242026 (partial year): 30
2007high 63 (2017) · low 24 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NKB

61in 2025

2007: 87 days median2008: 59 days median2009: 71 days median2010: 111 days median2011: 84 days median2012: 79 days median2013: 73 days median2014: 90 days median2015: 90 days median2016: 84 days median2017: 69 days median2018: 61 days median2019: 84 days median2020: 68 days median2021: 61 days median2022: 88 days median2023: 72 days median2024: 57 days median2025: 61 days median2026 (partial year): 91 days median
2007high 111 (2010) · low 57 (2024)2026

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

Recalls per year · NKB

1in 2025

2007: 42008: 52009: 332010: 42011: 32012: 132014: 3, 1 Class I2015: 32016: 12017: 12018: 32019: 12020: 12022: 52023: 22024: 32025: 12026 (partial year): 3
2007high 33 (2009) · low 0 (2013)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · NKB

1,171in 2025

2007: 342008: 822009: 1712010: 4622011: 5772012: 1,7472013: 1,9622014: 1,6712015: 1,4462016: 1,5852017: 1,6182018: 1,6842019: 1,9152020: 2,0762021: 1,7452022: 1,3392023: 9192024: 1,6142025: 1,171
2007high 2,076 (2020) · low 34 (2007)2025

MAUDE reports naming product code NKB, 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
20073887434
20083659582
2009447133171
2010371114462
201148843577
20126079131,747
2013357301,962
201446903 (1)1,671
2015559031,446
2016508411,585
2017636911,618
2018566131,684
2019398411,915
2020486812,076
2021326101,745
2022348851,339
202344722919
2024395731,614
2025246111,171
202630913—

What is it indicated for?

The ROMEO® 2 Posterior Osteosynthesis System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). When used…

Read the full statement (113 words)

The ROMEO® 2 Posterior Osteosynthesis System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). When used for posterior non-cervical pedicle screw fixation in pediatric patients, the ROMEO® 2 Posterior Osteosynthesis System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The ROMEO® 2 Posterior Osteosynthesis System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Indications for use as stated in the FDA summary.

Also cleared against K081165

11 other devices cite the same predicate.

  • K203506PERLA® TL posterior osteosynthesis systemSpineart · 20212 recalls
  • K203222PERLA TL Posterior Osteosynthesis SystemSpineart · 2020
  • K151695Romeo posterior osteosynthesis systemSpineart · 2015
  • K141835Romeo Posterior Osteosynthesis System Prebent Cross-Connectors; Prebent RodsSpineart · 2014
  • K140948Romeo Posterior Osteosynthesis SystemSpineart · 2014
  • K130267Romeo Posterior Osteosynthesis SystemSpineart · 2013

More from Spineart

44 FDA decisions under this applicant name. See the company

  • K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart · 2023
  • K213470PERLA® TL Posterior Osteosynthesis SystemSpineart · 2022
  • K210472SPINEART Navigation Instrument SystemSpineart · 2021
  • K203506PERLA® TL posterior osteosynthesis systemSpineart · 20212 recalls
  • K203222PERLA TL Posterior Osteosynthesis SystemSpineart · 2020

Recent decisions in NKB

The NKB category page

  • K261217AnyPlus II Spinal Fixation SystemGS Medical Co., Ltd. · 2026
  • K263062NOVIX Pedicle Screw SystemTdm Co., Ltd. · 2026
  • K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC · 2026
  • K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc. · 2026
  • K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd. · 2026

https://510kreport.com/device/K172101 · printed Nov 6, 2026

Cite this page

510(k) Report. “K172101: ROMEO® 2 Posterior Osteosynthesis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172101

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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