PMA P150017

Device: Cartiva Synthetic Cartilage Implant (SCI)
Applicant: Cartiva, Inc.
PMA number: P150017
Supplement: S015
Product code: PNW
Decision date: 2021-12-10
Generic name: Prosthesis, metatarsophalangeal joint cartilage replacement implant
Approval order 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.

Current openFDA PMA Record#

Device: Cartiva Synthetic Cartilage Implant (SCI)
Applicant: Cartiva, Inc.
PMA number: P150017
Supplement: S015
Product code: PNW
Generic name: Prosthesis, metatarsophalangeal joint cartilage replacement implant
Decision date: 2021-12-10
Decision code: APPR
Date received: 2021-06-30
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 Building C, 11576 Memphis-Arlington Road, Arlington, Tennessee 38002 as a secondary manufacturing and packaging site of Cartiva SCI devices.