PMA P000058S097

Device: INFUSE Bone Graft/Medtronic Interbody Fusion Device
Applicant: Medtronic Sofamor Danek USA, Inc.
PMA number: P000058
Supplement: S097
Product code: NEK
Decision date: 2026-02-24
Classification: Orthopedic
Generic name: Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
Approval order statement: Change to upgrade the EO Sterilization Chamber Control System at the contract sterilization site from the Antares Chamber Control System to the Konnexis AccuSOLO Chamber Control System

Current openFDA PMA Record#

Device: INFUSE Bone Graft/Medtronic Interbody Fusion Device
Applicant: Medtronic Sofamor Danek USA, Inc.
PMA number: P000058
Supplement: S097
Product code: NEK
Generic name: Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
Decision date: 2026-02-24
Decision code: OK30
Date received: 2026-01-28
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change to upgrade the EO Sterilization Chamber Control System at the contract sterilization site from the Antares Chamber Control System to the Konnexis AccuSOLO Chamber Control System