K241609
- 510(k) number
- K241609
- Device name
- Tornier Humeral Reconstruction System (Tornier HRS)
- Applicant
- Stryker Corporation (Tornier, Inc.) MN · US
- Product code
- KWS — Prosthesis, Shoulder, Semi-Constrained, Metal/Polyme
- Decision date
- 2024-09-10
- Date received
- 2024-06-05
- 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: K241609.pdf
Official FDA record: K241609
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.