K242865
- 510(k) number
- K242865
- Device name
- Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer
- Applicant
- Biocomposites, Ltd. GB
- Product code
- KWL — Prosthesis, Hip, Hemi-, Femoral, Metal
- Decision date
- 2025-06-12
- Date received
- 2024-09-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K242865.pdf
Official FDA record: K242865
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.