- Device
- TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis
- Applicant
- Stryker Leibinger, GmbH & Co KG
- PMA number
- P980052
- Supplement
- S014
- Product code
- LZD
- Generic name
- Joint, temporomandibular, implant
- Decision date
- 2024-07-30
- Decision code
- OK30
- Date received
- 2024-06-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the addition of an automated thermomechanical bonding machine for bonding of the UHMWPE round bar stock to preformed titanium mesh substrates within the fossa manufacturing process