PMA P000058S075
- Device
- INFUSE Bone Graft/Medtronic Interbody Fusion Device
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- PMA number
- P000058
- Supplement
- S075
- Product code
- NEK
- Decision date
- 2019-11-01
- 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
- Implementation of new instruments to assess percent solids in a collagen dispersion used in the manufacturing 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
- S075
- Product code
- NEK
- Generic name
- Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
- Decision date
- 2019-11-01
- Decision code
- OK30
- Date received
- 2019-09-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of new instruments to assess percent solids in a collagen dispersion used in the manufacturing of INFUSE Bone Graft.