PMA P000058S065
- Device
- Infuse (R) Bone Graft
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- PMA number
- P000058
- Supplement
- S065
- Product code
- NEK
- Decision date
- 2017-09-21
- Classification
- Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction
- 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 two additional interbody fusion devices, the Divergence-L Anterior/Oblique Lumbar Fusion System or the Pivox Oblique Lateral Spinal System, utilizing select open surgical procedures in conjunction with supplemental spinal fixation hardware, as well as modifying the surgical technique manual to allow surgeons to optionally wrap a resorbable suture around the fusion cage component to maintain the position of the Infuse Bone Graft within the central cavity of the fusion cage component.
Current openFDA PMA Record#
- Device
- Infuse (R) Bone Graft
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- PMA number
- P000058
- Supplement
- S065
- Product code
- NEK
- Generic name
- Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
- Decision date
- 2017-09-21
- Decision code
- APPR
- Date received
- 2017-04-28
- 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 two additional interbody fusion devices, the Divergence-L Anterior/Oblique Lumbar Fusion System or the Pivox Oblique Lateral Spinal System, utilizing select open surgical procedures in conjunction with supplemental spinal fixation hardware, as well as modifying the surgical technique manual to allow surgeons to optionally wrap a resorbable suture around the fusion cage component to maintain the position of the Infuse Bone Graft within the central cavity of the fusion cage component.