K253675
- 510(k) number
- K253675
- Device name
- OsteoRemedies Hip Spacer System
- Applicant
- Osteoremedies, LLC TN · US
- Product code
- KWL — Prosthesis, Hip, Hemi-, Femoral, Metal
- Decision date
- 2025-12-23
- Date received
- 2025-11-21
- 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: K253675.pdf
Official FDA record: K253675
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.