TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis
FDA premarket approval P980052/S014 · decided 2024-07-30
Approval details
- PMA number
- P980052
- Supplement
- S014
- 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
- 2024-06-04
- Decision date
- 2024-07-30
- Days to decision
- 56 days
- Decision code
- OK30
- Product code
- LZD
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Freiburg
- 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
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