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)
Top companies in MAX
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Sofamor Danek | 55 | 12 |
| Globus Medical, Inc. | 20 | 22 |
| Nu Vasive, Incorporated | 34 | 0 |
| Life Spine | 33 | 0 |
| Alphatec Spine | 21 | 3 |
| Spineology, Inc. | 22 | 0 |
| SeaSpine Orthopedics Corporation | 20 | 1 |
| Spinal Elements | 17 | 2 |
| Stryker | 17 | 0 |
| K2m | 13 | 3 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 9, 2026 | Medicrea International Medicrea, IB3D PL Instruments Set, Rx Only
REF: SPS03174 Open, Classified |
MAX | K241164 |
| Jan 9, 2026 | Medicrea International Medicrea, IB3D Universal Implant Inserter, Rx Only
REF: A24000000 Open, Classified |
MAX | K241164 |
| Dec 11, 2025 | Orthofix 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 |
MAX | K203576 |
| Dec 11, 2025 | Orthofix 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 |
MAX | K172437 |
| Nov 21, 2025 | Medtronic 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 |
MAX | K210425 |
| Sep 11, 2025 | Orthofix U.S. LLC PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP Open, Classified |
MAX | K240749 |
| Sep 11, 2025 | SEASPINE ORTHOPEDICS CORPORATION Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System Open, Classified |
MAX | K192132 |
| Mar 21, 2025 | Orthofix 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 |
MAX | K240749 |
| Jan 30, 2025 | Alphatec 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 |
MAX | K232504 |
| Sep 17, 2024 | Innovasis, 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 |
MAX | K180078 K183064 +1 |
| Apr 29, 2024 | Advanced 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 |
MAX | K173947 |
| Aug 24, 2023 | Medicrea International IMPIX S, REF numbers:
a) B15328071S,
b) B15328073S,
c) B15328074S,
d) B15334072S,
e) B15334073S,
f) B15334074S; intervertebral fusion device - cervical Open, Classified |
MAX | None listed |
| Aug 24, 2023 | Medicrea 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 |
MAX | K083798 |
| Aug 24, 2023 | Medicrea 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 |
MAX | K100544 |
| Aug 24, 2023 | Medicrea International IMPIX ALIF, REF numbers:
a) B15111209,
b) B15111212,
c) B15111409,
d) B15111412; intervertebral fusion device - lumbar Open, Classified |
MAX | K083798 |
| Aug 24, 2023 | Medicrea 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 |
MAX | K163595 |
| Jan 12, 2023 | CoreLink LLC CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208 Terminated |
MAX | K171519 |
| May 20, 2022 | DePuy 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 |
MAX | K170503 |
| May 20, 2022 | DePuy 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 |
MAX | K170503 |
| May 7, 2021 | K2M, 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 |
MAX | K150481 K172009 |
| May 7, 2021 | K2M, 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 |
MAX | K150481 K172009 |
| May 7, 2021 | K2M, 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 |
MAX | K150481 K172009 |
| Mar 17, 2021 | Medtronic 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 |
MAX | K141953 K183557 +1 |
| Mar 17, 2021 | Medtronic 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 |
MAX | K192018 |
| Mar 11, 2021 | Stryker 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 |
MAX | None listed |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x36, 12-16mm, 15 Terminated |
MAX | K140411 |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x36, 10-14mm, 15 Terminated |
MAX | K140411 |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x36, 9-13mm, 15 Terminated |
MAX | K140411 |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x36, 12-16mm, 8 Terminated |
MAX | K140411 |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x36, 10-14mm, 8 Terminated |
MAX | K140411 |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x36, 9-13mm, 8 Terminated |
MAX | K140411 |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x36, 8-12mm, 8 Terminated |
MAX | K140411 |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x31, 12-16mm, 15 Terminated |
MAX | K140411 |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x31, 10-14mm, 15 Terminated |
MAX | K140411 |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x31, 9-13mm, 15 Terminated |
MAX | K140411 |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x31, 12-16mm, 8 Terminated |
MAX | K140411 |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x31, 10-14mm, 8 Terminated |
MAX | K140411 |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x31, 9-13mm, 8 Terminated |
MAX | K140411 |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x31, 8-12mm, 8 Terminated |
MAX | K140411 |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x26, 12-16mm, 15 Terminated |
MAX | K140411 |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x26, 10-14mm, 15 Terminated |
MAX | K140411 |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x26, 9-13mm, 15 Terminated |
MAX | K140411 |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x26, 12-16mm, 8 Terminated |
MAX | K140411 |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x26, 10-14mm, 8 Terminated |
MAX | K140411 |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x26, 9-13mm, 8 Terminated |
MAX | K140411 |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x26, 8-12mm, 8 Terminated |
MAX | K140411 |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x31, 8-12mm, 8 (sterile) Terminated |
MAX | K140411 |
| Nov 22, 2019 | SPINEART SA Intersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures Terminated |
MAX | K153621 |
| Oct 2, 2019 | Medicrea International Medicrea TLIF-B Holder, short intended for Intervertebral body fusion device
Catalog: Number A24200010 Terminated |
MAX | K163595 |
| Aug 21, 2019 | CTL Medical Corporation CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H8mm, Part #018.1908. Completed |
MAX | K131981 |
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