- Device
- Infuse™ Bone Graft/Medtronic Interbody Fusion Device
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- PMA number
- P000058
- Supplement
- S087
- Product code
- NEK
- Generic name
- Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
- Decision date
- 2022-08-09
- Decision code
- OK30
- Date received
- 2022-07-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Replacement of the water purification system used in manufacture of the collagen sponge component.