PMA P000058S094

Device: INFUSE® Bone Graft/LT-Cage Lumbar Tapered Fusion Device
Applicant: Medtronic Sofamor Danek USA, Inc.
PMA number: P000058
Supplement: S094
Product code: NEK
Decision date: 2025-03-19
Classification: Orthopedic
Generic name: Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
Approval order statement: change of the current ePCD for ethylene oxide sterilization, change to the temperature and relative humidity monitoring, change to the finished good release of the collagen based medical devices

Current openFDA PMA Record#

Device: INFUSE® Bone Graft/LT-Cage Lumbar Tapered Fusion Device
Applicant: Medtronic Sofamor Danek USA, Inc.
PMA number: P000058
Supplement: S094
Product code: NEK
Generic name: Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
Decision date: 2025-03-19
Decision code: OK30
Date received: 2025-03-10
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: change of the current ePCD for ethylene oxide sterilization, change to the temperature and relative humidity monitoring, change to the finished good release of the collagen based medical devices