PMA P000058S078

Device: Infuse Bone Graft/Medtronic Interbody Fusion Device
Applicant: Medtronic Sofamor Danek USA, Inc.
PMA number: P000058
Supplement: S078
Product code: NEK
Decision date: 2020-07-10
Generic name: Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
Approval order statement: Optimization of the pre-sterilization phase set points of in-process autoclave cycles and addition of a second Tyvek wrapping for equipment, parts, and components sterilized in the in-process autoclaves.

Current openFDA PMA Record#

Device: Infuse Bone Graft/Medtronic Interbody Fusion Device
Applicant: Medtronic Sofamor Danek USA, Inc.
PMA number: P000058
Supplement: S078
Product code: NEK
Generic name: Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
Decision date: 2020-07-10
Decision code: OK30
Date received: 2020-06-11
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Optimization of the pre-sterilization phase set points of in-process autoclave cycles and addition of a second Tyvek wrapping for equipment, parts, and components sterilized in the in-process autoclaves.