Cartiva SCI
FDA premarket approval P150017/S009 · decided 2018-07-02
Approval details
- PMA number
- P150017
- Supplement
- S009
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Cartiva SCI
- Generic name
- Prosthesis, metatarsophalangeal joint cartilage replacement implant
- Applicant
- Cartiva, Inc.
- Date received
- 2018-06-06
- Decision date
- 2018-07-02
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- PNW
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Alpharetta, GA
- Statement
- Add an additional clean room for use in the manufacture of Cartiva SCI Implant.
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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 |