| Note: 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. |
| |
| Device | NORIAN SKELETAL REPAIR SYSTEM (SRS) CANCELLOUS BONE CEMENT |
|---|
| Generic Name | Filler, bone void, non-osteoinduction |
|---|
| Applicant | SYNTHES (USA)
1690 RUSSELL RD.
POST OFFICE BOX 1766
PAOLI, PA 19301 |
|---|
| PMA Number | P970010 |
|---|
| Date Received | 02/24/1997 |
|---|
| Decision Date | 12/23/1998 |
|---|
|
Reclassified Date
|
06/02/2003 |
|---|
| Product Code |
MBS |
| Docket Number | 99M-4361 |
|---|
| Notice Date | 10/20/1999 |
|---|
| Advisory Committee |
Orthopedic |
|---|
| Expedited Review Granted? | No |
|---|
| Combination Product | No |
|---|
Approval Order Statement
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. |
| Approval Order | Approval Order |
|---|
| Summary | Summary of Safety and Effectiveness |
|---|
| Labeling | Labeling
|
|---|
| Supplements: |
S001 S002 S004 |
|
|
