- Device
- TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis
- Applicant
- Stryker Leibinger, GmbH & Co KG
- PMA number
- P980052
- Supplement
- S017
- Product code
- LZD
- Generic name
- Joint, temporomandibular, implant
- Decision date
- 2026-03-06
- Decision code
- APPR
- Date received
- 2025-07-28
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the implementation of two (2) new sterile barrier heat sealing machines for use in the packaging process of patient-fitted TMJ implant