Patient-Fitted TMJ Reconstruction Prosthesis System
FDA premarket approval P980052/S009 · decided 2021-04-27
Approval details
- PMA number
- P980052
- Supplement
- S009
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Patient-Fitted TMJ Reconstruction Prosthesis System
- Generic name
- Joint, temporomandibular, implant
- Applicant
- Stryker Leibinger, GmbH & Co KG
- Date received
- 2020-12-11
- Decision date
- 2021-04-27
- Days to decision
- 137 days
- Decision code
- APPR
- Product code
- LZD
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Freiburg
- Statement
- Approval for heat treatment of surgical instruments by Solar Atmospheres, located at 8606 Live Oak Ave Fontana, CA.
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