TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis
FDA premarket approval P980052/S011 · decided 2022-08-31
Approval details
- PMA number
- P980052
- Supplement
- S011
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis
- Generic name
- Joint, temporomandibular, implant
- Applicant
- Stryker Leibinger, GmbH & Co KG
- Date received
- 2022-08-22
- Decision date
- 2022-08-31
- Days to decision
- 9 days
- Decision code
- OK30
- Product code
- LZD
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Freiburg
- Statement
- Addition of a back-up Ethylene Oxide Sterilizer.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.