PMA P860005S010

Device: PRO OSTEON IMPLANT 500 POROUS CORALLINE HYDROXYAPATITE BONE GRAFT SUBSTITUTE
Applicant: Interpore Intl.
PMA number: P860005
Supplement: S010
Product code: MBS
Decision date: 1998-01-08
Generic name: Filler, bone void, non-osteoinduction
Approval order statement: Approval for a change to the name of the product from "Bone Void Filler" to "Bone Graft Substitute." The device, as modified in designation, will be marketed under the trade name "Pro Osteon Implant 500 Porous Coralline Hydroxyapatite Bone Graft Substitute Blocks and Granules," and is indicated for the same indications approved in the original PMA and in P860006/S002.

Current openFDA PMA Record#

Device: PRO OSTEON IMPLANT 500 POROUS CORALLINE HYDROXYAPATITE BONE GRAFT SUBSTITUTE
Applicant: Interpore Intl.
PMA number: P860005
Supplement: S010
Product code: MBS
Generic name: Filler, bone void, non-osteoinduction
Decision date: 1998-01-08
Decision code: APPR
Date received: 1997-11-18
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for a change to the name of the product from "Bone Void Filler" to "Bone Graft Substitute." The device, as modified in designation, will be marketed under the trade name "Pro Osteon Implant 500 Porous Coralline Hydroxyapatite Bone Graft Substitute Blocks and Granules," and is indicated for the same indications approved in the original PMA and in P860006/S002.