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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namefiller, bone void, non-osteoinduction
Generic Namecollagen/hydroxyapatite bone graft substitute
ApplicantNEUCOLL, INC.
PMA NumberP900039
Date Received05/25/1990
Decision Date05/28/1993
Reclassified Date 06/02/2003
Product Code
MBS[ Registered Establishments with MBS ]
Docket Number 93M-0210
Notice Date 07/22/1993
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S005 S006 S007 S008 S009 S010 
S011 S012 S013 S015