K250346
- 510(k) number
- K250346
- Device name
- BonVie+
- Applicant
- Elute, Inc. UT · US
- Product code
- MQV — Filler, Bone Void, Calcium Compound
- Decision date
- 2025-02-26
- Date received
- 2025-02-06
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K250346.pdf
Official FDA record: K250346
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.