K242377
- 510(k) number
- K242377
- Device name
- REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component
- Applicant
- Osteoremedies, LLC TN · US
- Product code
- JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrai
- Decision date
- 2024-10-02
- Date received
- 2024-08-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K242377.pdf
Official FDA record: K242377
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.