TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
FDA premarket approval P020016/S002 · decided 2006-10-13
Approval details
- PMA number
- P020016
- Supplement
- S002
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
- Generic name
- Joint, temporomandibular, implant
- Applicant
- Biomet Microfixation, Inc.
- Date received
- 2006-09-11
- Decision date
- 2006-10-13
- Days to decision
- 32 days
- Decision code
- APPR
- Product code
- LZD
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT ARTHROTEK, INC.?S ONTARIO CALIFORNIA, FACILITY FOR THE PURCHASE OF RAW MATERIAL FOR THE MANDIBULAR BLANKS; THE CUTTING OF THIS RAW MATERIAL; AND THE ADDITION OF ANOTHER WIRE ELECTRICAL DISCHARGE MACHINE.
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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 |