INFUSE BONE GRAFT/Medtronic Interbody FUSION DEVICE
FDA premarket approval P000058/S060 · decided 2016-09-16
Approval details
- PMA number
- P000058
- Supplement
- S060
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INFUSE BONE GRAFT/Medtronic Interbody FUSION DEVICE
- Generic name
- Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- Date received
- 2016-06-21
- Decision date
- 2016-09-16
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- NEK
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- Approval for increasing the size of the bioreactor used to manufacture rhBMP-2 from 6000 L to 12,000 L at the Pfizer Andover, MA Facility.
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510(k) clearances by this applicant
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|---|---|---|
| Catalyft PL Expandable Interbody System (K253011) | Medtronic Sofamor Danek USA, Inc. | 2026-07-17 |
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| 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 |