K233261
- 510(k) number
- K233261
- Device name
- Global Modular Replacement System
- Applicant
- Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics NJ · US
- Product code
- JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Ce
- Decision date
- 2023-12-08
- Date received
- 2023-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K233261.pdf
Official FDA record: K233261
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.