TMJ Concepts Patient Fitted Temporomandibular Joint (TMJ) Reconstruction Prosthesis System
FDA premarket approval P980052/S016 · decided 2025-07-23
Approval details
- PMA number
- P980052
- Supplement
- S016
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TMJ Concepts Patient Fitted Temporomandibular Joint (TMJ) Reconstruction Prosthesis System
- Generic name
- Joint, temporomandibular, implant
- Applicant
- Stryker Leibinger, GmbH & Co KG
- Date received
- 2025-06-23
- Decision date
- 2025-07-23
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- LZD
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Freiburg
- Statement
- to modify the method of inspection of the articular surface of the Fossa component to utilize the MarSurf CM Explorer Microscope
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