Infuse Bone Graft
FDA premarket approval P000054/S062 · decided 2022-02-18
Approval details
- PMA number
- P000054
- Supplement
- S062
- Supplement type
- Normal 180 Day Track
- 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
- 2020-07-29
- Decision date
- 2022-02-18
- Days to decision
- 569 days
- Decision code
- APPR
- Product code
- MPW
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- Approval for extension of the expiration date from 18 to 24 months for three 1mg drug product lots manufactured at Hospira, Inc. (McPherson, Kansas) and seven 1mg drug product lots manufactured at Wyeth Farma S.A. (Algete, Spain) when stored at 5° and 30°C; addition of a 30 month timepoint to the long-term stability protocol studies performed at 30 ºC ± 2 ºC /75 ± 5% RH and 30 ºC ± 2 ºC /75 ± 5% RH; and discontinuation of testing at the 5°C long-term storage condition (current 5°C lots will cont
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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 |