510(k) Report

510(k) · Cleared

Cleared

ABTross ALIF Expandable Cage System

K221719510(k) TraditionalCleared Nov 3, 2022143-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

Aegis Spine, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Cleared on Nov 3, 2022 as substantially equivalent to K142498 (Globus Medical, Inc., 2015) and 7 other predicates after a 143-day review. Its family tree reaches back 23 generations to 1984. 2 later devices descend from it.

Decided
Nov 3, 2022
Review
143 days
Class
Class II
Product code
MAX
Recalls
None
Predicates
8

Its longest line of descent runs back 23 generations to K841189 (1984). 368 ancestors in all, the oldest K792352 (1979). 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2018: 2 other ancestors2015: 11 other ancestors2012: 20 other ancestors2011: 27 other ancestors2010: 24 other ancestors2008: 40 other ancestors2016: 5 other ancestors2013: 20 other ancestors2009: 29 other ancestors2007: 17 other ancestors2005: 24 other ancestors1999: 4 other ancestors2017: 1 other ancestor2014: 13 other ancestors2004: 38 other ancestors2001: 11 other ancestors2006: 14 other ancestors2003: 20 other ancestors2002: 13 other ancestors2000: 4 other ancestors1996: 3 other ancestors1993: 1 other ancestor1998: 2 other ancestors1980: 1 other ancestor1979: 1 other ancestor2023: 1 descendant cleared2024: 1 descendant 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. · 2011×2: 2 generations cleared close together, K121683 (2012), K123752 (2013) K132505 · Acculif TL and PL Cage · Coalign Innovations, Inc. · 2013 · recalled×2: 2 generations cleared close together, K141217 (2014), K143163 (2015) K150788 · Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion Devices, Talos -C (HA) Cervical Intervertebral Body Fusion Devices · Meditech Spine, LLC · 2015K160906 · Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device, Rampart A lumbar Interbody Fusion Device · Spineology, Inc. · 2016×2: 2 generations cleared close together, K162879 (2017), K171425 (2017) K190708 · AccelFix Lumbar Interbody Fusion Cage System · L&K BIOMED Co., Ltd. · 2019K203531 · XYPAN Expandable Lumbar Cage System · Aegis Spine, Inc. · 202119801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 7 other ancestors2 generations back: 14 other ancestors3 generations back: 24 other ancestors4 generations back: 41 other ancestors5 generations back: 40 other ancestors6 generations back: 55 other ancestors7 generations back: 58 other ancestors8 generations back: 58 other ancestors9 generations back: 26 other ancestors10 generations back: 17 other ancestors11 generations back: 4 other ancestors12 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 1 descendant K203531 · XYPAN Expandable Lumbar Cage System · Aegis Spine, Inc. · 2021K190708 · AccelFix Lumbar Interbody Fusion Cage System · L&K BIOMED Co., Ltd. · 2019K171425 · Concorde Lift · Medos International SARL · 2017 · recalledK162879 · Elite Expandable Interbody Fusion Device · Spineology, Inc. · 2017K160906 · Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device, Rampart A lumbar Interbody Fusion Device · Spineology, Inc. · 2016K150788 · Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion Devices, Talos -C (HA) Cervical Intervertebral Body Fusion Devices · Meditech Spine, LLC · 2015K143163 · 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
  1. Root · 23 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 19 generations between
  3. 3 generations backK171425 Concorde LiftMedos International SARL · 2017 · Recalled
  4. 2 generations backK190708 AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd. · 2019
  5. 1 generation backK203531 XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc. · 2021
  6. This deviceK221719 ABTross ALIF Expandable Cage SystemAegis Spine, Inc. · 2022
  7. Descendant · cites it directly · 1 of its ownK223474 PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd. · 2023
  8. Descendant · 2 generations on · 0 of its ownK242829 BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd. · 2024
Show all 23 generations
  1. Root · 23 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 22 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 21 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 20 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 19 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 18 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
  7. 17 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
  8. 16 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
  9. 15 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
  10. 14 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
  11. 13 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
  12. 12 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
  13. 11 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
  14. 10 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
  15. 9 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
  16. 8 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
  17. 7 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
  18. 6 generations backK150788 Talos Intervertebral Body Fusion Devices, Talos -C Cervical…Meditech Spine, LLC · 2015
  19. 5 generations backK160906 Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody…Spineology, Inc. · 2016
  20. 4 generations backK162879 Elite Expandable Interbody Fusion DeviceSpineology, Inc. · 2017
  21. 3 generations backK171425 Concorde LiftMedos International SARL · 2017 · Recalled
  22. 2 generations backK190708 AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd. · 2019
  23. 1 generation backK203531 XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc. · 2021
  24. This deviceK221719 ABTross ALIF Expandable Cage SystemAegis Spine, Inc. · 2022

Most influential descendants

Showing 2 of 2 · See all
  • K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd. · 2023 · cites it directly1descendant
  • K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd. · 2024 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−23K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−22K990148Stackable Cage SystemDepuy Motech Acromed1999—
−21K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−20K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−19K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−18K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH2004—
−17K042930Spacevision Cage SystemSpine Vision, Inc.2004—
−16K062759Paramount VBR SystemInnovative Spinal Technologies, Inc.2007—
−15K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.2007—
−14K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008—
−13K094025Crescent Spinal SystemMedtronic Sofamor Danek2010—
−12K110543Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc.2011—
−11K121683Acculif TL CageCoalign Innovations, Inc.2012—
−10K123752Acculif TL and PL CageCoalign Innovations, Inc.2013—
−9K132505Acculif TL and PL CageCoalign Innovations, Inc.20133
−8K141217Acculif TL and PL CageStryker Corporation20143
−7K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK…Stryker Corporation2015—
−6K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral…Meditech Spine, LLC2015—
−5K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion…Spineology, Inc.2016—
−4K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.2017—
−3K171425Concorde LiftMedos International SARL20172
−2K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.2019—
−1K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.2021—
0 (this device)K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.2022—
+1K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.2023—
+2K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198010
199310
199630
199820
199940
200040
2001110
2002130
2003200
2004380
2005240
2006140
2007170
2008400
2009290
2010240
2011270
2012200
2013200
2014130
2015110
201650
201710
201820

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202310
202410
FIG. 1 — Lineage of K221719, 1984–2024Source: 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 MAX? 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 MAX device

  1. #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 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
*K142498MAGNIFY and MAGNIFY-S Spacers
Summary page 4
…The subject ABTross ALIF Expandable Cage System is substantially equivalent to the following devices: Primary Predicate Device  MAGNIFY TM Spacer System(K142498) Additional Predicate Devices  XYPAN Expandable Lumbar Cage (XL, XTP) System(K203531)  Xenco Medical Lum…
Globus Medical, Inc.2015—
*K203531XYPAN Expandable Lumbar Cage System
Summary page 4
…s: Primary Predicate Device  MAGNIFY TM Spacer System(K142498) Additional Predicate Devices  XYPAN Expandable Lumbar Cage (XL, XTP) System(K203531)  Xenco Medical Lumbar Interbody System(K143158)  Vu a POD Intervertebral Body Fusion Device (K080822/K121211…
Aegis Spine, Inc.2021—
*K143158Xenco Medical Lumbar Interbody System
Summary page 4
…acer System(K142498) Additional Predicate Devices  XYPAN Expandable Lumbar Cage (XL, XTP) System(K203531)  Xenco Medical Lumbar Interbody System(K143158)  Vu a POD Intervertebral Body Fusion Device (K080822/K121211/K173606)  AnyPlus PEEK Cages (ALIF) (K100516/K1…
Xenco Medical, LLC2015—
*K080822VU Apod Intervertabral Body Fusion Device
Summary page 4
… XYPAN Expandable Lumbar Cage (XL, XTP) System(K203531)  Xenco Medical Lumbar Interbody System(K143158)  Vu a POD Intervertebral Body Fusion Device (K080822/K121211/K173606)  AnyPlus PEEK Cages (ALIF) (K100516/K111354) 4. DESCRIPTION OF THE DEVICE The ABTross ALIF Exp…
Theken Spine, LLC20081
*K121211VU Apod Intervertebral Body Fusion Device
Summary page 4
…Expandable Lumbar Cage (XL, XTP) System(K203531)  Xenco Medical Lumbar Interbody System(K143158)  Vu a POD Intervertebral Body Fusion Device (K080822/K121211/K173606)  AnyPlus PEEK Cages (ALIF) (K100516/K111354) 4. DESCRIPTION OF THE DEVICE The ABTross ALIF Expandable…
Theken Spine, LLC2012—
*K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…
Summary page 4
…le Lumbar Cage (XL, XTP) System(K203531)  Xenco Medical Lumbar Interbody System(K143158)  Vu a POD Intervertebral Body Fusion Device (K080822/K121211/K173606)  AnyPlus PEEK Cages (ALIF) (K100516/K111354) 4. DESCRIPTION OF THE DEVICE The ABTross ALIF Expandable Cage Sys…
SeaSpine Orthopedics Corporation2018—
*K100516Anyplus Peek Cages
Summary page 4
… Xenco Medical Lumbar Interbody System(K143158)  Vu a POD Intervertebral Body Fusion Device (K080822/K121211/K173606)  AnyPlus PEEK Cages (ALIF) (K100516/K111354) 4. DESCRIPTION OF THE DEVICE The ABTross ALIF Expandable Cage System is interbody fusion devices. This cage syst…
GS Medical Co., Ltd.2010—
*K111354GS Medical Anyplus Peek Lumbar Cages (Alif and Dlif)
Summary page 4
…co Medical Lumbar Interbody System(K143158)  Vu a POD Intervertebral Body Fusion Device (K080822/K121211/K173606)  AnyPlus PEEK Cages (ALIF) (K100516/K111354) 4. DESCRIPTION OF THE DEVICE The ABTross ALIF Expandable Cage System is interbody fusion devices. This cage system is ma…
GS Medical Co., Ltd.2011—

Also cleared against K142498: 7 other devices →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231

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 38 years and passes through 16 companies; a new generation was cleared every 10 months on median.
  • 35 of the 368 ancestors have a recall of any class.
  • Of its descendants, K223474 (L&K BIOMED Co., Ltd., 2023) has gone furthest, with 1 descendant of its own.
  • 7 other devices also cite its predicate K142498.

How does its category compare?

All MAX devices

MAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.

FDA decisions per year · MAX

29in 2025

2007: 72008: 352009: 312010: 292011: 492012: 482013: 582014: 582015: 532016: 642017: 762018: 642019: 602020: 562021: 532022: 412023: 302024: 382025: 292026 (partial year): 18
2007high 76 (2017) · low 7 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAX

85in 2025

2007: 86 days median2008: 88 days median2009: 102 days median2010: 137 days median2011: 98 days median2012: 69 days median2013: 102 days median2014: 115 days median2015: 113 days median2016: 124 days median2017: 116 days median2018: 114 days median2019: 131 days median2020: 106 days median2021: 109 days median2022: 95 days median2023: 87 days median2024: 91 days median2025: 85 days median2026 (partial year): 95 days median
2007high 137 (2010) · low 69 (2012)2026

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

Recalls per year · MAX

5in 2025

2008: 22009: 92011: 32012: 11, 1 Class I2014: 32015: 12016: 62017: 12018: 42019: 12022: 12024: 12025: 5
2007high 11 (2012) · low 0 (2007)2026

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

Adverse event reports per year · MAX

811in 2025

2007: 122008: 192009: 902010: 1542011: 2012012: 3272013: 3802014: 3662015: 5242016: 6472017: 5962018: 6162019: 6992020: 6402021: 6222022: 6182023: 5762024: 7292025: 811
2007high 811 (2025) · low 12 (2007)2025

MAUDE reports naming product code MAX, 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
2007786012
20083588219
200931102990
2010291370154
201149983201
2012486911 (1)327
2013581020380
2014581153366
2015531131524
2016641246647
2017761161596
2018641144616
2019601311699
2020561060640
2021531090622
202241951618
202330870576
202438911729
202529855811
202618950—

What is it indicated for?

ABTross ALIF Expandable Cage System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) to facilitate fusion. ABTross ALIF Expandable Cage System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment…

Read the full statement (179 words)

ABTross ALIF Expandable Cage System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) to facilitate fusion. ABTross ALIF Expandable Cage System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should have at least six months of non-operative treatment prior to treatment with a lumbar intervertebral fusion device. The device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.

Indications for use as stated in the FDA summary.

Also cleared against K142498

7 other devices cite the same predicate.

  • K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd. · 2023
  • K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc. · 2023
  • K211740DualXAmplify Surgical, Inc. · 2021
  • K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, ELSA…Globus Medical, Inc. · 2021
  • K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO Corpectomy Spacers…Globus Medical, Inc. · 2017
  • K170157INDEPENDENCE® SpacersGlobus Medical, Inc. · 2017

More from Aegis Spine, Inc.

5 FDA decisions under this applicant name. See the company

  • K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc. · 2023
  • K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc. · 2023
  • K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate…Aegis Spine, Inc. · 2022
  • K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc. · 2021

Recent decisions in MAX

The MAX category page

  • K262646Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX…Alphatec Spine, Inc. · 2026
  • K261049Scala® TLSpineart SA · 2026
  • K261430TruLift Expandable SystemLife Spine, Inc. · 2026
  • K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2026
  • K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2026

https://510kreport.com/device/K221719 · printed Nov 6, 2026

Cite this page

510(k) Report. “K221719: ABTross ALIF Expandable Cage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221719

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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