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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePRO OSTEON 500 BONE GRAFT SUBSTITUTE
Generic NameFiller, bone void, non-osteoinduction
ApplicantInterpore Intl.
181 Technology Dr.
Irvine, CA 92618
PMA NumberP860005
Supplement NumberS012
Date Received12/04/2001
Decision Date05/31/2002
Reclassified Date06/02/2003
Product Codes LMN MBS 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO REPLACE STATIC COMPRESSION TESTING WITH ULTIMATE COMPRESSION TESTING DURING THE MANUFACTURING PROCESS FOLLOWING DEPYROGENATION.
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