510(k) Report

510(k) · Cleared

Recalled · Class II · 2022

G21 Cement, VADER® Pedicle System

K200596510(k) TraditionalCleared Oct 13, 2020221-day reviewClass II21 CFR 888.3027Recalls 1

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

Icotec AG · PML Bone Cement, Posterior Screw Augmentation

Cleared on Oct 13, 2020 as substantially equivalent to K150408 (G21, S.R.L., 2015) and 6 other predicates after a 221-day review. Its family tree reaches back 20 generations to 2004. 1 of the 362 devices in its family, counting itself, has a Class I recall. 27 later devices descend from it. It has been recalled once.

Decided
Oct 13, 2020
Review
221 days
Class
Class II
Product code
PML
Recalls
1
Predicates
7

Its longest line of descent runs back 20 generations to K040583 (2004). 334 ancestors in all, the oldest P810020 (1984). 27 later devices descend from it, 7 citing it directly. 1 of the 362 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2019: 1 other ancestor2018: 2 other ancestors2016: 5 other ancestors2015: 2 other ancestors2012: 3 other ancestors2008: 13 other ancestors2017: 3 other ancestors2013: 3 other ancestors2011: 9 other ancestors2007: 16 other ancestors2005: 24 other ancestors1999: 16 other ancestors2010: 15 other ancestors, 1 with a Class I recall12009: 16 other ancestors2006: 19 other ancestors2004: 31 other ancestors2003: 21 other ancestors2002: 17 other ancestors2001: 20 other ancestors2000: 20 other ancestors1998: 14 other ancestors1997: 9 other ancestors1996: 8 other ancestors1995: 9 other ancestors1994: 3 other ancestors1984: 2 other ancestors2014: 2 other ancestors1993: 3 other ancestors1992: 5 other ancestors1990: 2 other ancestors1985: 1 other ancestor2023: 7 descendants cleared2024: 9 descendants cleared2022: 1 descendant cleared2025: 5 descendants cleared2026: 5 descendants cleared×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) K121680 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2012×2: 2 generations cleared close together, K131321 (2013), K132111 (2013) K141604 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2014K143684 · NuVasive Reline System · Nu Vasive, Incorporated · 2015K160989 · NuVasive® Reline® System · Nu Vasive, Incorporated · 2016K180498 · NuVasive Reline Fenestrated Screws, High V+ Bone Cement · Nu Vasive, Incorporated · 2018K190526 · High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws · CarboFix Orthopedics, Ltd. · 201919801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors2 generations back: 12 other ancestors3 generations back: 47 other ancestors4 generations back: 61 other ancestors5 generations back: 69 other ancestors6 generations back: 47 other ancestors, 1 with a Class I recall17 generations back: 38 other ancestors8 generations back: 25 other ancestors9 generations back: 9 other ancestors 1 generation forward: 7 descendants2 generations forward: 8 descendants3 generations forward: 8 descendants4 generations forward: 4 descendants K190526 · High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws · CarboFix Orthopedics, Ltd. · 2019K180498 · NuVasive Reline Fenestrated Screws, High V+ Bone Cement · Nu Vasive, Incorporated · 2018K160989 · NuVasive® Reline® System · Nu Vasive, Incorporated · 2016K143684 · NuVasive Reline System · Nu Vasive, Incorporated · 2015K141604 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2014K132111 · CD Horizon Spinal System · Medtronic Sofamor Danek USA · 2013K131321 · CD Horizon Spinal System · Medtronic Sofamor Danek USA · 2013K121680 · 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 · 2004−20−15−10−50
  1. Root · 20 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 16 generations between
  3. 3 generations backK160989 NuVasive® Reline® SystemNu Vasive, Incorporated · 2016
  4. 2 generations backK180498 NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated · 2018
  5. 1 generation backK190526 High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd. · 2019
  6. This deviceK200596 G21 Cement, VADER® Pedicle SystemIcotec AG · 2020
  7. Descendant · cites it directly · 14 of its ownK221926 Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc. · 2022
  8. Descendant · 2 generations on · 11 of its ownK232275 Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2023
  9. Descendant · cites it directly · 5 of its ownK222789 VADER® Pedicle System, G21 CementIcotec AG · 2023 · Recalled
  10. Descendant · 3 generations on · 4 of its ownK242364 IdentiTi™ II Interbody SystemAlphatec Spine, Inc. · 2024
  11. Descendant · cites it directly · 4 of its ownK231280 CarboClear® X Pedicle Screw System; CarboClear® X Navigated…CarboFix Orthopedics, Ltd. · 2023
Show all 20 generations
  1. Root · 20 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 19 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 18 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 17 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 16 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 15 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 14 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 13 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 12 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 11 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 10 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 9 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. 8 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  14. 7 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
  15. 6 generations backK132111 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
  16. 5 generations backK141604 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
  17. 4 generations backK143684 NuVasive Reline SystemNu Vasive, Incorporated · 2015
  18. 3 generations backK160989 NuVasive® Reline® SystemNu Vasive, Incorporated · 2016
  19. 2 generations backK180498 NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated · 2018
  20. 1 generation backK190526 High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd. · 2019
  21. This deviceK200596 G21 Cement, VADER® Pedicle SystemIcotec AG · 2020

Showing 5 of 27 descendants. See all descendants

Descendants cleared per year

2022: 12023: 72024: 92025: 52026: 5
2022high 9 (2024) · low 1 (2022)2026

Class I recalls in this family

  • K100952 Modification to Synthes Matrix System6 generations back · 2010

Most influential descendants

Showing 5 of 27 · See all
  • K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc. · 2022 · cites it directly14descendants
  • K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2023 · 2 generations on11descendants
  • K222789VADER® Pedicle System, G21 CementIcotec AG · 2023 · cites it directly5descendants
  • K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc. · 2024 · 3 generations on4descendants
  • K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd. · 2023 · cites it directly4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−20K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−19K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−18K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−17K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−16K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−15K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−14K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−13K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−12K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−11K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−10K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−9K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
−8K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012—
−7K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013—
−6K132111CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013—
−5K141604CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014—
−4K143684NuVasive Reline SystemNu Vasive, Incorporated2015—
−3K160989NuVasive® Reline® SystemNu Vasive, Incorporated2016—
−2K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated2018—
−1K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.2019—
0 (this device)K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020—
+1K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.2022—
+2K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.2023—
+1K222789VADER® Pedicle System, G21 CementIcotec AG20232
+3K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.2024—
+1K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments…CarboFix Orthopedics, Ltd.2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198420
198510
199020
199250
199330
199430
199590
199680
199790
1998140
1999160
2000200
2001200
2002170
2003210
2004310
2005240
2006190
2007160
2008130
2009160
2010151
201190
201230
201330
201420
201520
201650
201730
201820
201910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202210
202370
202490
202550
202650
FIG. 1 — Lineage of K200596, 2004–2026Source: 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 PML device

  1. #1 K221926 Invictus® Bone Cement, Invictus Spinal…score 22.3 · 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? (7)

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
*K150408V-Steady, V-Fast
Summary page 7
…ed pedicle screws. The VADER® Pedicle System can be used for single or multiple level fixations in the non-cervical spine. Primary Predicate Devices: Steady and V-Fast (K150408) Additional Predicate Devices: • icotec VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 (K190545)…
G21, S.R.L.2015—
*K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0
Summary page 7
…imary Predicate Devices: Steady and V-Fast (K150408) Additional Predicate Devices: • icotec VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 (K190545) • icotec Pedicle System (K151977) • Blackstone Pedicle Screw System (K082797) • Corelink Tiger Spine System (K113…
Icotec AG20191
*K151977icotec Pedicle System
Summary page 7
…ast (K150408) Additional Predicate Devices: • icotec VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 (K190545) • icotec Pedicle System (K151977) • Blackstone Pedicle Screw System (K082797) • Corelink Tiger Spine System (K113058) • CarboFix Pedicle Screw Syst…
Icotec AG2016—
*K082797Blackstone Pedicle Screw System
Summary page 7
…• icotec VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 (K190545) • icotec Pedicle System (K151977) • Blackstone Pedicle Screw System (K082797) • Corelink Tiger Spine System (K113058) • CarboFix Pedicle Screw System (K182377) • CarboClear Fenestrated Pedicl…
Blackstone Medical, Inc.2008—
*K113058Tiger Spine System
Summary page 7
…ightMore® Pedicle System 6.0 (K190545) • icotec Pedicle System (K151977) • Blackstone Pedicle Screw System (K082797) • Corelink Tiger Spine System (K113058) • CarboFix Pedicle Screw System (K182377) • CarboClear Fenestrated Pedicle Screws, High V+ Bone Cement (K190526) Perf…
Corelink, LLC2012—
*K182377CarboClear® Pedicle Screw System
Summary page 7
…• icotec Pedicle System (K151977) • Blackstone Pedicle Screw System (K082797) • Corelink Tiger Spine System (K113058) • CarboFix Pedicle Screw System (K182377) • CarboClear Fenestrated Pedicle Screws, High V+ Bone Cement (K190526) Performance Testing Summary: The testing of the VAD…
CarboFix Orthopedics, Ltd.2018—
*K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws
Summary page 7
…(K082797) • Corelink Tiger Spine System (K113058) • CarboFix Pedicle Screw System (K182377) • CarboClear Fenestrated Pedicle Screws, High V+ Bone Cement (K190526) Performance Testing Summary: The testing of the VADER® Pedicle System includes: • ASTM F543 Screw Testing • ASTM F17…
CarboFix Orthopedics, Ltd.2019—

What descends from it? (27)

See all 27

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

NumberDeviceApplicantDecidedDescendants
K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214
K222789VADER® Pedicle System, G21 CementIcotec AG20235
K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234
K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242
K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231
K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240
K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230

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

Recalls of this device

DateClassRecallRoot causeReason
Nov 3, 2022Class IIZ-0728-2023Nonconforming Material/ComponentDuring internal testing (at manufacturer site) of two torque wrench devices, it was detected that the torque limiting function was out of specification. The specified torque limiting value is 12 Nm. The measuring results for both…

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 · 6 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 7 months on median.
  • 40 of the 334 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K221926 (Alphatec Spine, Inc., 2022) has gone furthest, with 14 descendants of its own.

How does its category compare?

All PML devices

PML Bone Cement, Posterior Screw Augmentation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.

FDA decisions per year · PML

1in 2024

2016: 22017: 12018: 22019: 22020: 32021: 12022: 22023: 32024: 12026 (partial year): 2
2007high 3 (2020) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PML

116in 2023

2020: 182 days median2023: 116 days median
2007high 182 (2020) · low 116 (2023)2026

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

Recalls per year · PML

2in 2023

2023: 2
2007high 2 (2023) · low 0 (2007)2026

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

Adverse event reports per year · PML

55in 2025

2017: 12018: 342019: 352020: 272021: 322022: 122023: 182024: 602025: 55
2007high 60 (2024) · low 0 (2007)2025

MAUDE reports naming product code PML, 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
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20162—00
20171—01
20182—034
20192—035
20203182027
20211—032
20222—012
20233116218
20241—060
20250—055
20262—0—

What is it indicated for?

When used in conjunction with the icotec VADER® Pedicle System, G21 V-Fast and V-Steady Bone Cement are 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 thoracic and lumbar spine in whom life expectancy, prior to oncological treatment, is of insufficient duration to permit achievement of fusion. The fenestrated VADER® one pedicle screws 6.0 augmented…

Read the full statement (289 words)

When used in conjunction with the icotec VADER® Pedicle System, G21 V-Fast and V-Steady Bone Cement are 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 thoracic and lumbar spine in whom life expectancy, prior to oncological treatment, is of insufficient duration to permit achievement of fusion. The fenestrated VADER® one pedicle screws 6.0 augmented with G21 V-Fast or V-Steady Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

The VADER® Pedicle 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, prior to oncological treatment, is of insufficient duration to permit achievement of fusion.

When used in conjunction with G21 V-Fast or V-Steady Bone Cement and PicoMix™ V and/or V-HP Gun with the icotec Cement Cannula for mixing and injection of bone cements, the fenestrated VADER® pedicle screws 6.0 are 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, prior to oncological treatment, is of insufficient duration to permit achievement of fusion. The fenestrated VADER® pedicle screws 6.0 augmented with G21 V-Fast or V-Steady Bone Cement are limited to the use at spinal levels where the structural integrity of the spine is not severely compromised.

The VADER® Pedicle System is indicated to provide the surgeon with a minimally invasive and open approach for posterior spinal surgery.

Indications for use as stated in the FDA summary.

More from Icotec AG

16 FDA decisions under this applicant name. See the company

  • K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG · 2025
  • K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG · 2025
  • K233215icotec Anterior Cervical Plate SystemIcotec AG · 2024
  • K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn™ TLIF Lumbar Cage)Icotec AG · 2024
  • K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG · 2024

Recent decisions in PML

The PML category page

  • K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc. · 2026
  • K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical · 2026
  • K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A. · 2024
  • K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal…Ulrich Medical USA · 2023
  • K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart · 2023

https://510kreport.com/device/K200596 · printed Nov 3, 2026

Cite this page

510(k) Report. “K200596: G21 Cement, VADER® Pedicle System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200596

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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