- Device
- Cartiva Synthetic Cartilage Implant (Cartiva SCI)
- Applicant
- Cartiva, Inc.
- PMA number
- P150017
- Supplement
- S010
- Product code
- PNW
- Generic name
- Prosthesis, metatarsophalangeal joint cartilage replacement implant
- Decision date
- 2019-07-11
- Decision code
- APPR
- Date received
- 2018-10-05
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the addition of 6 mm and 12 mm sizes of the Cartiva SCI device to the previously approved 8 mm and 10 mm sizes of the device.