CARTIVA SYNTHETIC CARTILAGE IMPLANT
FDA premarket approval P150017/S005 · decided 2017-03-01
Approval details
- PMA number
- P150017
- Supplement
- S005
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CARTIVA SYNTHETIC CARTILAGE IMPLANT
- Generic name
- Prosthesis, metatarsophalangeal joint cartilage replacement implant
- Applicant
- Cartiva, Inc.
- Date received
- 2017-01-31
- Decision date
- 2017-03-01
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- PNW
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Alpharetta, GA
- Statement
- Approval for modifications to the Surgical Implantation Technique Guide for the Cartiva Synthetic Cartilage Implant to enhance safe use of the device.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |