TMJ CONCEPTS PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS
FDA premarket approval P980052 · decided 1999-07-02
Approval details
- PMA number
- P980052
- Trade name
- TMJ CONCEPTS PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS
- Generic name
- Joint, temporomandibular, implant
- Applicant
- Stryker Leibinger, GmbH & Co KG
- Date received
- 1999-01-06
- Decision date
- 1999-07-02
- Days to decision
- 177 days
- Decision code
- APPR
- Product code
- LZD
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Freiburg
- Statement
- Approval for the TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis. The device is indicated for reconstruction of the temporomandibular joint. Patients should be considered if they have one or more of the following conditions: 1) Inflammaotry arthritis involving the temporomandibular joint not responsive to other modalities of treatment; 2) Recurrent fibrous and/or bony ankylosis not responsive to other modalities of treatment; 3) Failed tissue graft; 4) Loss of vertical mandibular heigh
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