TOTAL TEMPOROMANDIBULAR JOINT (TMJ) REPLACEMENT SYSTEM
FDA premarket approval P020016/S008 · decided 2017-06-08
Approval details
- PMA number
- P020016
- Supplement
- S008
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- TOTAL TEMPOROMANDIBULAR JOINT (TMJ) REPLACEMENT SYSTEM
- Generic name
- Joint, temporomandibular, implant
- Applicant
- Biomet Microfixation, Inc.
- Date received
- 2016-12-14
- Decision date
- 2017-06-08
- Days to decision
- 176 days
- Decision code
- APPR
- Product code
- LZD
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- APPROVAL FOR PROPOSED LABELING CHANGES FOLLOWING THE CONCLUSION OF THE POSTMARKET SURVEILLANCE STUDY FOR THE TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM (K111908) | Biomet Microfixation, Inc. | 2011-11-29 |
| BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEM (K110574) | Biomet Microfixation, Inc. | 2011-05-18 |
| ADKINS STRUT (K091058) | Biomet Microfixation, Inc. | 2009-07-22 |
| FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE) (K081067) | Biomet Microfixation, Inc. | 2008-05-09 |
| BIOMET MICROFIXATION LACTOSORB PECTUS STABILIZER (K071577) | Biomet Microfixation, Inc. | 2007-09-06 |