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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
Classification Namefiller, bone void, non-osteoinduction
Generic Namefiller, bone void, non-osteoinduction
1690 russell rd.
post office box 1766
paoli, PA 19301
PMA NumberP970010
Date Received02/24/1997
Decision Date12/23/1998
Reclassified Date 06/02/2003
Product Code
MBS[ Registered Establishments with MBS ]
Docket Number 99M-4361
Notice Date 10/20/1999
Advisory Committee Physical Medicine
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