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.
| Device | TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM |
| Generic Name | Joint, Temporomandibular, Implant |
| Applicant | BIOMET MICROFIXATION, INC. |
| Date Received | 2006-09-11 |
| Decision Date | 2006-10-13 |
| PMA | P020016 |
| Supplement | S002 |
| Product Code | LZD |
| Advisory Committee | Dental |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BIOMET MICROFIXATION, INC. 1520 Tradeport Dr. jacksonville, FL 32218 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P020016 | | Original Filing |
| S011 |
2019-11-18 |
30-day Notice |
| S010 | | |
| S009 | | |
| S008 |
2016-12-14 |
Normal 180 Day Track No User Fee |
| S007 |
2014-11-10 |
30-day Notice |
| S006 |
2012-01-27 |
30-day Notice |
| S005 |
2010-05-18 |
Normal 180 Day Track No User Fee |
| S004 |
2009-12-02 |
Real-time Process |
| S003 |
2009-09-24 |
Real-time Process |
| S002 |
2006-09-11 |
Normal 180 Day Track No User Fee |
| S001 |
2006-04-28 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices