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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.
 
DevicePRO OSTEON IMPLANT 500 HYDROXYAPATITE BONE VOID FILLER
Classification Namecalcium salt bone void filler, drillable, non-screw augmentation
Generic Namecalcium salt bone void filler, drillable, non-screw augmentation
Regulation Number888.3045
Applicant
INTERPORE INTL.
181 technology dr.
irvine, CA 92618-2402
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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