PMA P000058S088

Device: Infuse Bone Graft
Applicant: Medtronic Sofamor Danek USA, Inc.
PMA number: P000058
Supplement: S088
Product code: NEK
Decision date: 2023-08-25
Classification: Orthopedic
Generic name: Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
Approval order statement: Approval for expansion of the approved indications for use of INFUSE® Bone Graft to include implantation with additional interbody fusion devices, a subset of the Anteralign Spinal System with Titan NanoLOCK Surface Technology, specifically the specified sizes of the Anteralign LS and TL systems, utilizing select open surgical procedures in conjunction with supplemental spinal fixation hardware or alone.

Current openFDA PMA Record#

Device: Infuse Bone Graft
Applicant: Medtronic Sofamor Danek USA, Inc.
PMA number: P000058
Supplement: S088
Product code: NEK
Generic name: Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
Decision date: 2023-08-25
Decision code: APPR
Date received: 2023-05-30
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for expansion of the approved indications for use of INFUSE® Bone Graft to include implantation with additional interbody fusion devices, a subset of the Anteralign Spinal System with Titan NanoLOCK Surface Technology, specifically the specified sizes of the Anteralign LS and TL systems, utilizing select open surgical procedures in conjunction with supplemental spinal fixation hardware or alone.