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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.
 
Trade NamePRO OSTEON IMPLANT 500 HYDROXYAPATITE BONE VOID FILLER
Classification Namecalcium salt bone void filler, drillable, non-screw augmentation
Generic Namebone graft non-osteogenic
Regulation Number888.3045
ApplicantINTERPORE INTL.
PMA NumberP860005
Date Received02/10/1986
Decision Date10/29/1992
Reclassified Date 06/02/2003
Product Code
OIS[ Registered Establishments with OIS ]
Docket Number 92M-0450
Notice Date 04/19/1993
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005 S007 S008 S009 S010 
S011 S012 
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