INFUSE BONE GRAFT
FDA premarket approval P000054/S001 · decided 2004-06-10
Approval details
- PMA number
- P000054
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- INFUSE BONE GRAFT
- Generic name
- Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- Date received
- 2004-05-20
- Decision date
- 2004-06-10
- Days to decision
- 21 days
- Decision code
- APPR
- Product code
- MPW
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- APPROVAL FOR 1) AN INCREASE IN THE EXPIRATION DATE OF THE 4.2 AND 12 MG VIALED RHBMP-2 COMPONENT OF THE REFERENCED DEVICES FROM 36 TO 48 MONTHS; 2) AN INCREASE IN THE EXPIRATION DATE OF THE COMMERCIAL KIT COMPONENT FROM 24 TO 36 MONTHS; AND 3) THE PROTOCOL TO BE FOLLOWED FOR ALL FUTURE EXPIRATION DATE CHANGES.
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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 |