This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Indicated for use as an adjunct for fracture stabilization in the treatment of low impact, unstable, metaphyseal distal radius fractures, in cases where early mobilization (cast for 2 weeks, then removable splint for 2-4 weeks) is indicated. Use of srs alone in highly comminuted fractures is not indicated.
| Device | NORIAN SKELETAL REPAIR SYSTEM (SRS) CANCELLOUS BONE CEMENT |
| Classification Name | Filler, Bone Void, Non-osteoinduction |
| Generic Name | Filler, Bone Void, Non-osteoinduction |
| Applicant | SYNTHES (USA) |
| Date Received | 1997-02-24 |
| Decision Date | 1998-12-23 |
| Notice Date | 1999-10-20 |
| PMA | P970010 |
| Supplement | S |
| Product Code | MBS |
| Docket Number | 99M-4361 |
| Advisory Committee | Orthopedic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SYNTHES (USA) 1690 Russell Rd. post Office Box 1766 paoli, PA 19301 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P970010 | Original Filing | |
| S004 | 2000-06-06 | Normal 180 Day Track |
| S003 | ||
| S002 | 2000-03-02 | Normal 180 Day Track |
| S001 | 1999-02-08 | Normal 180 Day Track |