PMA P000054

Device: Infuse™ Bone Graft
Applicant: Medtronic Sofamor Danek USA, Inc.
PMA number: P000054
Supplement: S068
Product code: MPW
Decision date: 2026-07-28
Generic name: Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction
Approval order statement: Approval to offer an alternatively configured Infuse™ Bone Graft kit in which the sterile water for injection (sWFI) vials, syringes, and needles have been removed from the kit, as well as minor labeling changes associated with this alternative kit configuration.

Current openFDA PMA Record#

Device: Infuse™ Bone Graft
Applicant: Medtronic Sofamor Danek USA, Inc.
PMA number: P000054
Supplement: S078
Product code: MPW
Generic name: Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction
Decision date: 2026-07-28
Decision code: APPR
Date received: 2026-04-29
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval to offer an alternatively configured Infuse™ Bone Graft kit in which the sterile water for injection (sWFI) vials, syringes, and needles have been removed from the kit, as well as minor labeling changes associated with this alternative kit configuration.