PMA P150017S007
- Device
- Cartiva SCI reusable instrumentation
- Applicant
- Cartiva, Inc.
- PMA number
- P150017
- Supplement
- S007
- Product code
- PNW
- Decision date
- 2018-08-28
- Classification
- Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant
- Generic name
- Prosthesis, metatarsophalangeal joint cartilage replacement implant
- Approval order statement
- Approval for a manufacturing site located at Arcamed LLC, 5101 Decatur Blvd Ste A, Indianapolis, Indiana to manufacture the instruments for Cartiva Synthetic Cartilage Implant.
Current openFDA PMA Record#
- Device
- Cartiva SCI reusable instrumentation
- Applicant
- Cartiva, Inc.
- PMA number
- P150017
- Supplement
- S007
- Product code
- PNW
- Generic name
- Prosthesis, metatarsophalangeal joint cartilage replacement implant
- Decision date
- 2018-08-28
- Decision code
- APPR
- Date received
- 2017-11-15
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing site located at Arcamed LLC, 5101 Decatur Blvd Ste A, Indianapolis, Indiana to manufacture the instruments for Cartiva Synthetic Cartilage Implant.