PMA P860005S009

Device: PRO OSTEON IMPLANT 500 POROUS HYDROXYAPATITE BONE GRAFT SUBSTITUTE BLOCKS & GRANULES
Applicant: Interpore Intl.
PMA number: P860005
Supplement: S009
Product code: MBS
Decision date: 1998-04-28
Generic name: Filler, bone void, non-osteoinduction
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.

Current openFDA PMA Record#

Device: PRO OSTEON IMPLANT 500 POROUS HYDROXYAPATITE BONE GRAFT SUBSTITUTE BLOCKS & GRANULES
Applicant: Interpore Intl.
PMA number: P860005
Supplement: S009
Product code: MBS
Generic name: Filler, bone void, non-osteoinduction
Decision date: 1998-04-28
Decision code: APPR
Date received: 1997-10-27
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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.