Cartiva Synthetic Cartilage Implant (SCI)
FDA premarket approval P150017/S015 · decided 2021-12-10
Approval details
- PMA number
- P150017
- Supplement
- S015
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Cartiva Synthetic Cartilage Implant (SCI)
- Generic name
- Prosthesis, metatarsophalangeal joint cartilage replacement implant
- Applicant
- Cartiva, Inc.
- Date received
- 2021-06-30
- Decision date
- 2021-12-10
- Days to decision
- 163 days
- Decision code
- APPR
- Product code
- PNW
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Alpharetta, GA
- Statement
- Approval for a manufacturing site located at Building C, 11576 Memphis-Arlington Road, Arlington, Tennessee 38002 as a secondary manufacturing and packaging site of Cartiva SCI devices.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Cartiva SCI instrumentation set (K192156) | Cartiva, Inc. | 2019-09-04 |
| Cartiva SCI Disposable Instrumentation Set (K181348) | Cartiva, Inc. | 2018-06-20 |
| ProxiFuse Hammer Toe Device (K142490) | Cartiva, Inc. | 2014-12-15 |