- Device
- INFUSE™ Bone Graft/Medtronic Interbody Fusion Device
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- PMA number
- P000058
- Supplement
- S093
- Product code
- NEK
- Generic name
- Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
- Decision date
- 2024-11-06
- Decision code
- OK30
- Date received
- 2024-10-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- change for the replacement of the data acquisition (DAQ) system component on the shrink temperature testing instrument in the quality control (QC) analytical lab