K250141
- 510(k) number
- K250141
- Device name
- Synthecure Synthetic Calcium Sulfate
- Applicant
- Austin Medical Ventures, Inc. TN · US
- Product code
- MQV — Filler, Bone Void, Calcium Compound
- Decision date
- 2025-05-16
- Date received
- 2025-01-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250141.pdf
Official FDA record: K250141
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.