- Device
- Patient-Fitted TMJ Reconstruction Prosthesis System
- Applicant
- Stryker Leibinger, GmbH & Co KG
- PMA number
- P980052
- Supplement
- S009
- Product code
- LZD
- Generic name
- Joint, temporomandibular, implant
- Decision date
- 2021-04-27
- Decision code
- APPR
- Date received
- 2020-12-11
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for heat treatment of surgical instruments by Solar Atmospheres, located at 8606 Live Oak Ave Fontana, CA.