Infuse TM Bone Graft/Medtronic lnterbody Fusion Device
FDA premarket approval P000058/S099 · decided 2026-07-28
Approval details
- PMA number
- P000058
- Supplement
- S099
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Infuse TM Bone Graft/Medtronic lnterbody Fusion Device
- Generic name
- Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- Date received
- 2026-04-29
- Decision date
- 2026-07-28
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- NEK
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- Approval to offer an alternatively configured Infuse Bone Graft kit in which the sterile water for injection (sWFI) vials, syringes, and needles have been removed from the kit, as well as minor labeling changes associated with this alternative kit configuration.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Catalyft PL Expandable Interbody System (K253011) | Medtronic Sofamor Danek USA, Inc. | 2026-07-17 |
| Symmetrix™ L Spinal System (K261020) | Medtronic Sofamor Danek USA, Inc. | 2026-07-14 |
| OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System (K253656) | Medtronic Sofamor Danek USA, Inc. | 2026-06-05 |
| CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal System (K260216) | Medtronic Sofamor Danek USA, Inc. | 2026-04-21 |
| Infinity™ OCT System (K254165) | Medtronic Sofamor Danek USA, Inc. | 2026-01-21 |
| CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly) (K253941) | Medtronic Sofamor Danek USA, Inc. | 2026-01-07 |
| Infinity™ OCT System (K253129) | Medtronic Sofamor Danek USA, Inc. | 2025-10-24 |
| CD Horizon™ Spinal System (K253335) | Medtronic Sofamor Danek USA, Inc. | 2025-10-24 |