K231556
- 510(k) number
- K231556
- Device name
- SPECTRUM® GV Bone Cement
- Applicant
- Osteoremedies, LLC TN · US
- Product code
- LOD — Bone Cement
- Decision date
- 2023-12-20
- Date received
- 2023-05-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K231556.pdf
Official FDA record: K231556
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.