Home › Device types › MAX
Intervertebral Fusion Device With Bone Graft, Lumbar
FDA product code MAX · Class 2 · Orthopedic
174,971
Registered devices
9,297
Adverse events
115
Recalls
896
510(k) clearances
Devices with this code
ALEUTIAN® Interbody Systems — VB Spine LLCCASCADIA™ Interbody System — VB Spine LLCFIX-L PEEK PLIF and T-PLIF System — Jeil Medical CorporationPeridot-PT Intervertebral body fusion system — GBS Commonwealth Co.,Ltd.LnK Lumbar Interbody Fusion Cage System — L&K BIOMED CO. ,LTD.4CIS PEEK PLIF CAGE SYSTEM — ALPHA AI CO.,LTD.Peridot-PT Intervertebral body fusion system — GBS Commonwealth Co.,Ltd.Peridot-TD Intervertebral body fusion system — GBS Commonwealth Co.,Ltd.Peridot-TD Intervertebral body fusion system — GBS Commonwealth Co.,Ltd.Savant Lumbar Interbody Fusion System — CURITEVA, INC.EZ-Track — NEXT ORTHOSURGICAL, INC.Ventana L — SPINAL ELEMENTS, INC.MONDRIAN Lumbar Interbody Fusion Cage System — CTL Medical CorporationRODIN Expandable Lumbar Cage System — CTL Medical CorporationImpulse Interbody Spacer System — DEGEN MEDICAL, INC.Solar™ Interbody Fusion System — DEGEN MEDICAL, INC.Solar™ Interbody Fusion System — DEGEN MEDICAL, INC.CASCADIA™ Interbody System — VB Spine LLCYellowstone — SUMMIT SPINE LLCTirboLOX-L Lumbar IBFD — CAPTIVA SPINE, INC.TirboLOX-L Lumbar IBFD — CAPTIVA SPINE, INC.Transcend — ALPHATEC SPINE, INC.Tritanium PL — Stryker CorporationFortilink-L IBF System — Pioneer Surgical Technology, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | Orthofix U.S. LLC | Labeling contains claims that are not consistently present. |
| 2025-11-03 | Orthofix U.S. LLC | Labeling contains claims that are not consistently present. |
| 2025-10-29 | Medicrea International | Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant. |
| 2025-10-29 | Medicrea International | Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant. |
| 2025-09-16 | Medtronic Sofamor Danek USA Inc | Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Theref |
| 2025-08-06 | SEASPINE ORTHOPEDICS CORPORATION | Inserter, used as part of a system with an intervertebral body fusion device, may contribute to difficulty disengaging the implant or improper implant positioni |
| 2025-06-24 | Orthofix U.S. LLC | A 37 mm implant width intervertebral body fusion device has a labeling discrepancy with incorrect width of 33 mm stated on the outer label side flap and inner l |
| 2025-02-20 | Orthofix U.S. LLC | The product is mislabeled with the incorrect anterior height of 10mm, but the laser marking on the implant and corresponding trial both show the correct anterio |
| 2024-12-15 | Alphatec Spine, Inc. | Complaints have been received regarding post-operative implant collapse. |
| 2024-08-14 | Innovasis, Inc | Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device. |
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