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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NamePRO OSTEON IMPLANT 500 POROUS HYDROXYAPATITE BONE GRAFT SUBSTITUTE BLOCKS & GRANULES
Classification Namefiller, bone void, non-osteoinduction
Generic Namebone graft non-osteogenic
ApplicantINTERPORE INTL.
PMA NumberP860005
Supplement NumberS009
Date Received10/27/1997
Decision Date04/28/1998
Product Code
MBS[ Registered Establishments with MBS ]
Advisory Committee Physical Medicine
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for several labeling changes as identified and agreed upon in an april 17, 1998 facsimile of the labeling. The device name will also be modified and will be marketed under the trade name "pro osteon(r) implant 500 porous hydroxyapatite bone graft substitute blocks and granules. " the device is indicated for the repair of metaphyseal fracture defects and long bone cyst and tumor defects. For metaphyseal fracture defects, the device is indicated for treatment which occurs within one month of fracture. The device is to be used in conjunction with rigid internal fixation as dictated by the clinical use requirements in skeletally mature individuals.
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