Home › Device types › MAX
Intervertebral Fusion Device With Bone Graft, Lumbar
FDA product code MAX · Class 2 · Orthopedic
172,335
Registered devices
9,183
Adverse events
115
Recalls
895
510(k) clearances
Devices with this code
IVA Cage Ti — DIOMEDICAL CO.,LTD.IVA Cage Ti — DIOMEDICAL CO.,LTD.IVA Cage Ti — DIOMEDICAL CO.,LTD.Peridot Intervertebral body fusion system — GBS Commonwealth Co.,Ltd.Peridot Intervertebral body fusion system — GBS Commonwealth Co.,Ltd.Peridot Intervertebral body fusion system — GBS Commonwealth Co.,Ltd.Peridot Intervertebral body fusion system — GBS Commonwealth Co.,Ltd.Peridot Intervertebral body fusion system — GBS Commonwealth Co.,Ltd.IVA Cage — DIOMEDICAL CO.,LTD.Peridot Intervertebral body fusion system — GBS Commonwealth Co.,Ltd.Peridot Intervertebral body fusion system — GBS Commonwealth Co.,Ltd.SKYHAWK — Orthofix US LLCFORZA PTC — Orthofix US LLCPeridot Intervertebral body fusion system — GBS Commonwealth Co.,Ltd.TALOS® IBF — MEDITECH SPINE, LLCPeridot-PT Intervertebral body fusion system — GBS Commonwealth 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.Yellowstone — SUMMIT SPINE LLCValeo Spacer System — SINTX Technologies, Inc.Valeo Spacer System — SINTX Technologies, Inc.Endoskeleton TL — TITAN SPINE, LLCTiNano — AURORA SPINE, 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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