Bloomington, MN, US · 3 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | Class II | Orthopedic | 2 | 2024-12-06 |
| PHX | Shoulder Prosthesis, Reverse Configuration | Class II | Orthopedic | 1 | 2026-06-12 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-06-12 | K260102 | Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System | PHX | Class II | Orthopedic |
| 2024-12-06 | K241878 | Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem) | KWS | Class II | Orthopedic |
| 2024-09-10 | K241609 | Tornier Humeral Reconstruction System (Tornier HRS) | KWS | Class II | Orthopedic |