| Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device. |
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| Trade Name | NORIAN SKELETAL REPAIR SYSTEM (SRS) CANCELLOUS BONE CEMENT |
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| Classification Name | filler, bone void, non-osteoinduction |
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| Applicant | SYNTHES (USA) |
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| PMA Number | P970010 |
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| Date Received | 02/24/1997 |
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| Decision Date | 12/23/1998 |
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Reclassified Date
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06/02/2003 |
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| Product Code | |
| Docket Number | 99M-4361 |
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| Notice Date | 10/20/1999 |
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| Advisory Committee |
Physical Medicine |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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| Information About: |
Labeling, Approval Order, Summary of Safety and Effectiveness |
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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
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| Supplements: |
S001 S002 S004 |
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