- Device
- TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis
- Applicant
- Stryker Leibinger, GmbH & Co KG
- PMA number
- P980052
- Supplement
- S015
- Product code
- LZD
- Generic name
- Joint, temporomandibular, implant
- Decision date
- 2024-08-08
- Decision code
- OK30
- Date received
- 2024-08-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- change of the current Process Challenge Device (PCD) used during the in-house 100% ethylene oxide (EO) sterilization of the Patient-Fitted TMJ Implants at the TMJ Concepts facility located in Ventura, CA