K233490
- 510(k) number
- K233490
- Device name
- SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty
- Applicant
- Bioventus, LLC NC · US
- Product code
- MQV — Filler, Bone Void, Calcium Compound
- Decision date
- 2023-12-05
- Date received
- 2023-10-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K233490.pdf
Official FDA record: K233490
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.