K251686
- 510(k) number
- K251686
- Device name
- Tornier Humeral Reconstruction System Max (Tornier HRS Max)
- Applicant
- Tornier, Inc. MN · US
- Product code
- KWT — Prosthesis, Shoulder, Non-Constrained, Metal/Polymer
- Decision date
- 2025-10-30
- Date received
- 2025-06-02
- 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: K251686.pdf
Official FDA record: K251686
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.