PMA P000058

Device: Infuse TM Bone Graft/Medtronic lnterbody Fusion Device
Applicant: Medtronic Sofamor Danek USA, Inc.
PMA number: P000058
Supplement: S087
Product code: NEK
Decision date: 2026-07-28
Generic name: Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, 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 TM Bone Graft/Medtronic lnterbody Fusion Device
Applicant: Medtronic Sofamor Danek USA, Inc.
PMA number: P000058
Supplement: S099
Product code: NEK
Generic name: Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, 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.