INFUSE BONE GRAFT
FDA premarket approval P000054/S004 · decided 2005-04-20
Approval details
- PMA number
- P000054
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INFUSE BONE GRAFT
- Generic name
- Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- Date received
- 2005-01-26
- Decision date
- 2005-04-20
- Days to decision
- 84 days
- Decision code
- APPR
- Product code
- MPW
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- APPROVAL FOR TWO CHANGES TO THE PROCESSING OF THE RHBMP-2 COMPONENT OF THE DEVICE - THE USE OF A NEW WORKING CELL BANK AND THE USE OF A LONGER HOLD-TIME (<=120 HOURS AT 2-8 DEGREES C COMPARED TO THE CURRENT 24 HOURS) FOR THE MATREX CELLUFINE SULFATE COLUMN.
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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 |