ClearanceBrief
Panels › Orthopedic › Product code MAX · Class 2

Intervertebral Fusion Device With Bone Graft, Lumbar

Regulation 888.3080

19510(k)s in 12 months (896 all time)
5recalls in 12 months (116 all time)
105recalls that name a 510(k)
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Top companies in MAX

DateFirm and productCodeLinked 510(k)
Jan 9, 2026Medicrea International
Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174
Open, Classified
MAXK241164
Jan 9, 2026Medicrea International
Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000
Open, Classified
MAXK241164
Dec 11, 2025Orthofix U.S. LLC
Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System Model/Catalog Number: 38-2006SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 6H; 38-2007SP FORZA Ti Spacer, Straight, 0, 9W x 23L
Open, Classified
MAXK203576
Dec 11, 2025Orthofix U.S. LLC
Brand Name: FORZA" PTC Spacer System Product Name: FORZA" PTC Spacer System Model/Catalog Number: 38-1007SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 7H 38-1008SP FORZA PTC Spacer, Straight, 0, 9W x 2
Open, Classified
MAXK172437
Nov 21, 2025Medtronic Sofamor Danek USA Inc
Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers: 1. SPACER 6068073 CATALYFT PL SHORT 7MM. Model Number: 6068073. 2. SPACER 6068076 CATALYFT PL LONG
Open, Classified
MAXK210425
Sep 11, 2025Orthofix U.S. LLC
PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP
Open, Classified
MAXK240749
Sep 11, 2025SEASPINE ORTHOPEDICS CORPORATION
Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System
Open, Classified
MAXK192132
Mar 21, 2025Orthofix U.S. LLC
Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant grade titanium alloy: (1) REF 82-3300SP, 33mm W x 24mm D x 10mm H, 7 degrees; (2) REF 82-3700SP, 37mm W
Open, Classified
MAXK240749
Jan 30, 2025Alphatec Spine, Inc.
Calibrate CCX Interbody System for spinal fusion procedures: Implants: (1) Calibrate CCX-O, 7 x 10 x 25mm 5 degrees, Part #325-07102505, nonsterile; (2) Calibrate CCX-O, 7 x 10 x 25mm 10 degree
Open, Classified
MAXK232504
Sep 17, 2024Innovasis, Inc
TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF System is an intervertebral body fusion device intended to stabilize a spinal segment to promote fusion using bone gr
Open, Classified
MAXK180078
K183064 +1
Apr 29, 2024Advanced Research Medical, LLC
ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System (OLLIF), Flexible Curette Loop Blade, Part # 01-06-4; treatment of degenerative disc disease
Completed
MAXK173947
Aug 24, 2023Medicrea International
IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B15334073S, f) B15334074S; intervertebral fusion device - cervical
Open, Classified
MAXNone listed
Aug 24, 2023Medicrea International
IMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, d) B15130613S, e) B15130615S, f) B15900806, g) B15900906, h) B15901006, i) B15901106, j) B15901206, k) B15901306; inte
Open, Classified
MAXK083798
Aug 24, 2023Medicrea International
IMPIX DLIF, REF numbers: a) B16123509, b) B16123511, c) B16124009, d) B16124013, e) B16124509, f) B16124511, g) B16124513, h) B16164009, i) B16164013, j) B16165009, k) B16165013; interver
Open, Classified
MAXK100544
Aug 24, 2023Medicrea International
IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) B15111412; intervertebral fusion device - lumbar
Open, Classified
MAXK083798
Aug 24, 2023Medicrea International
IMPIX 3D, REF numbers: a) B242C09122810, b) B242C10062810, c) B242C10122810, d) B242C11062810, e) B242C11122810, f) B242C12062810, g) B242C12122810, h) B242C12123310, i) B242C13062810, j)
Open, Classified
MAXK163595
Jan 12, 2023CoreLink LLC
CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208
Terminated
MAXK171519
May 20, 2022DePuy Spine, Inc.
EIT CIF cage, H 7mm, 8degree, S- an intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DDD) Part Number: CUI
Open, Classified
MAXK170503
May 20, 2022DePuy Spine, Inc.
EIT CIF cage, H 6mm, 8degree, L- an intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DDD). Part Number: CUI
Open, Classified
MAXK170503
May 7, 2021K2M, Inc
Cascadia AN Interbody Convex 10x28x14mm Catalog Number: 6101-2102814NC-G2 Lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft compris
Terminated
MAXK150481
K172009
May 7, 2021K2M, Inc
Cascadia AN Interbody Convex 10x22x15mm Catalog Number: 6101-2102215NC-G2 Lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft compris
Terminated
MAXK150481
K172009
May 7, 2021K2M, Inc
Cascadia AN Interbody Convex 10x22x14mm Catalog Number: 6101-2102214NC-G2 Lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised
Terminated
MAXK150481
K172009
Mar 17, 2021Medtronic Sofamor Danek USA, Inc
Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Large, 8 mm, Product Number 5146-1608-N - Product Usage: indicated to be used with supplemental fixation cleared by t
Terminated
MAXK141953
K183557 +1
Mar 17, 2021Medtronic Sofamor Danek USA, Inc
Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Small, 8 mm, Product Number 5146-1208-N - Product Usage: indicated to be used with supplemental fixation cleared by t
Terminated
MAXK192018
Mar 11, 2021Stryker Spine
Tritanium X TL Instruments - intervertebral fusion device with bone graft, lumbar. Catalogs:TL Inserter (580220100), TL Draw Rod (580220101), Tube Set/Syringe Adapter Assembly (680220100), Syringe Plu
Terminated
MAXNone listed
Aug 22, 2020Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 15
Terminated
MAXK140411
Aug 22, 2020Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 15
Terminated
MAXK140411
Aug 22, 2020Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 15
Terminated
MAXK140411
Aug 22, 2020Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 8
Terminated
MAXK140411
Aug 22, 2020Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 8
Terminated
MAXK140411
Aug 22, 2020Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 8
Terminated
MAXK140411
Aug 22, 2020Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x36, 8-12mm, 8
Terminated
MAXK140411
Aug 22, 2020Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 15
Terminated
MAXK140411
Aug 22, 2020Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 15
Terminated
MAXK140411
Aug 22, 2020Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 15
Terminated
MAXK140411
Aug 22, 2020Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 8
Terminated
MAXK140411
Aug 22, 2020Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 8
Terminated
MAXK140411
Aug 22, 2020Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 8
Terminated
MAXK140411
Aug 22, 2020Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8
Terminated
MAXK140411
Aug 22, 2020Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 15
Terminated
MAXK140411
Aug 22, 2020Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 15
Terminated
MAXK140411
Aug 22, 2020Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 15
Terminated
MAXK140411
Aug 22, 2020Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 8
Terminated
MAXK140411
Aug 22, 2020Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 8
Terminated
MAXK140411
Aug 22, 2020Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 8
Terminated
MAXK140411
Aug 22, 2020Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x26, 8-12mm, 8
Terminated
MAXK140411
Aug 22, 2020Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8 (sterile)
Terminated
MAXK140411
Nov 22, 2019SPINEART SA
Intersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures
Terminated
MAXK153621
Oct 2, 2019Medicrea International
Medicrea TLIF-B Holder, short intended for Intervertebral body fusion device Catalog: Number A24200010
Terminated
MAXK163595
Aug 21, 2019CTL Medical Corporation
CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H8mm, Part #018.1908.
Completed
MAXK131981

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