This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for modifications to the bone screw length to match thelabeled lengths, to standardize the screw thread profile and pitch, to increase the length of the threaded portion of the bone screw, to round the tip of the screw, to add a fillet between the screw head and screw shaft, to standardize dimensions of certain geometrical features of the bone screws (the screw head crown radius and driver slot depth), to standardize the minor diameter, and to introduce ti-6al-4v alloy bone screws.
| Device | TMJ FOSSA-EMINENCE AND CONDYLAR PROSTHESIS SYSTEM |
| Generic Name | Joint, Temporomandibular, Implant |
| Applicant | NEXUS CMF, LLC |
| Date Received | 2014-03-04 |
| Decision Date | 2014-06-02 |
| PMA | P000023 |
| Supplement | S009 |
| Product Code | LZD |
| Advisory Committee | Dental |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | NEXUS CMF, LLC 17301 West Colfax Avenue suite 170 golden, CO 80401 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P000023 | Original Filing | |
| S011 | 2015-01-16 | 30-day Notice |
| S010 | 2014-05-02 | 30-day Notice |
| S009 | 2014-03-04 | Real-time Process |
| S008 | 2012-05-03 | 135 Review Track For 30-day Notice |
| S007 | 2011-08-29 | Normal 180 Day Track No User Fee |
| S006 | 2011-05-11 | Normal 180 Day Track No User Fee |
| S005 | ||
| S004 | 2002-12-26 | Normal 180 Day Track |
| S003 | 2002-06-20 | Normal 180 Day Track |
| S002 | 2002-06-20 | Normal 180 Day Track |
| S001 | 2002-06-18 | Normal 180 Day Track |