K241716
- 510(k) number
- K241716
- Device name
- Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component
- Applicant
- Howmedica Osteonics Corp., Dba Stryker Orthopaedics NJ · US
- Product code
- JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Ce
- Decision date
- 2024-08-02
- Date received
- 2024-06-14
- 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: K241716.pdf
Official FDA record: K241716
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.