- Device
- TMJ Concepts Patient Fitted Temporomandibular Joint (TMJ) Reconstruction Prosthesis System
- Applicant
- Stryker Leibinger, GmbH & Co KG
- PMA number
- P980052
- Supplement
- S016
- Product code
- LZD
- Generic name
- Joint, temporomandibular, implant
- Decision date
- 2025-07-23
- Decision code
- APPR
- Date received
- 2025-06-23
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to modify the method of inspection of the articular surface of the Fossa component to utilize the MarSurf CM Explorer Microscope