PMA P000058S098

Device: INFUSE® Bone Graft/LT-Cage Lumbar Tapered Fusion Device
Applicant: Medtronic Sofamor Danek USA, Inc.
PMA number: P000058
Supplement: S098
Product code: NEK
Decision date: 2026-03-19
Classification: Orthopedic
Generic name: Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
Approval order statement: addition of an alternate testing facility and relocation of relevant laboratories to a new building

Current openFDA PMA Record#

Device: INFUSE® Bone Graft/LT-Cage Lumbar Tapered Fusion Device
Applicant: Medtronic Sofamor Danek USA, Inc.
PMA number: P000058
Supplement: S098
Product code: NEK
Generic name: Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
Decision date: 2026-03-19
Decision code: OK30
Date received: 2026-02-17
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: addition of an alternate testing facility and relocation of relevant laboratories to a new building