PMA P000058S074

Device: Infuse Bone Graft/Medtronic Interbody Fusion Device
Applicant: Medtronic Sofamor Danek USA, Inc.
Product code: NEK
Decision date: 2019-12-13
Generic name: Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
Approval order statement: Approval for an additional configuration of the vials used for the sterile water for injection used to reconstitute the lyophilized rhBMP-2 component of Infuse Bone Graft.

Current openFDA PMA Record#

Device: Infuse Bone Graft/Medtronic Interbody Fusion Device
Applicant: Medtronic Sofamor Danek USA, Inc.
PMA number: P000058
Supplement: S074
Product code: NEK
Generic name: Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
Decision date: 2019-12-13
Decision code: APPR
Date received: 2019-09-18
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for an additional configuration of the vials used for the sterile water for injection used to reconstitute the lyophilized rhBMP-2 component of Infuse Bone Graft.