PMA P000058S095

Device: INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE
Applicant: Medtronic Sofamor Danek USA, Inc.
PMA number: P000058
Supplement: S095
Product code: NEK
Decision date: 2026-08-26
Classification: Orthopedic
Generic name: Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
Approval order statement: Approval for a change to the potency testing of rhBMP-2 used in the manufacturing of INFUSE Bone Graft.

Current openFDA PMA Record#

Device: INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE
Applicant: Medtronic Sofamor Danek USA, Inc.
PMA number: P000058
Supplement: S095
Product code: NEK
Generic name: Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
Decision date: 2026-08-26
Decision code: APPR
Date received: 2025-03-14
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a change to the potency testing of rhBMP-2 used in the manufacturing of INFUSE Bone Graft.