Villanova Di San Daniele Del Friuli, IT · 26 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| MBF | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | Class II | Orthopedic | 6 | 2024-01-11 |
| PHX | Shoulder Prosthesis, Reverse Configuration | Class II | Orthopedic | 5 | 2026-01-22 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Class II | Orthopedic | 4 | 2025-05-22 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class II | Orthopedic | 4 | 2024-01-18 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Class II | Orthopedic | 2 | 2025-08-29 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Class II | Orthopedic | 1 | 2023-07-11 |
| PKC | Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained | Class II | Orthopedic | 1 | 2023-03-17 |
| QHE | — | — | — | 1 | 2022-12-20 |
| JDB | Prosthesis, Elbow, Semi-Constrained, Cemented | Class II | Orthopedic | 1 | 2022-10-26 |
| HTY | — | — | — | 1 | 2021-02-05 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-01-22 | K252352 | SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System | PHX | Class II | Orthopedic |
| 2025-08-29 | K251718 | ArTT Augments and Buttresses and Bone Screws | LPH | Class II | Orthopedic |
| 2025-07-03 | K243826 | SMR Reverse HP Shoulder System | PHX | Class II | Orthopedic |
| 2025-05-22 | K250980 | Physica System (Physica CR Porous Femoral components) | MBH | Class II | Orthopedic |
| 2024-12-18 | K243615 | Physica Porous Femoral Components | MBH | Class II | Orthopedic |
| 2024-01-18 | K234011 | AMF TT Cones | JWH | Class II | Orthopedic |
| 2024-01-11 | K233712 | PRIMA Humeral System; PRIMA TT Glenoid | MBF | Class II | Orthopedic |
| 2023-12-21 | K231099 | SMR Hybrid Glenoid System | MBF | Class II | Orthopedic |
| 2023-07-11 | K231925 | MINIMA S System | LZO | Class II | Orthopedic |
| 2023-03-17 | K221758 | SMR Stemless Anatomic | PKC | Class II | Orthopedic |
| 2023-02-03 | K223876 | SMR Shoulder System | MBF | Class II | Orthopedic |
| 2022-12-20 | K222405 | Smart SPACE Shoulder Planner and 3D Positioners | QHE | — | — |
| 2022-10-26 | K222807 | TEMA Elbow system - Line extension | JDB | Class II | Orthopedic |
| 2022-10-06 | K222427 | PRIMA TT Glenoid | MBF | Class II | Orthopedic |
| 2022-05-19 | K220792 | SMR Reverse Liner | MBF | Class II | Orthopedic |
| 2022-02-25 | K212800 | PRIMA Humeral System and SMR Glenosphere Ø42 | PHX | Class II | Orthopedic |
| 2021-12-17 | K213381 | Physica system | JWH | Class II | Orthopedic |
| 2021-07-12 | K210717 | Bone Screws dia. 5,0 mm | PHX | Class II | Orthopedic |
| 2021-04-06 | K210554 | Physica system | MBH | Class II | Orthopedic |
| 2021-02-05 | K203475 | LimaCorporate Kirschner Wire | HTY | — | — |
| 2020-12-17 | K201905 | SMR 140° Reverse Humeral Body | MBF | Class II | Orthopedic |
| 2020-12-14 | K201084 | Physica system | MBH | Class II | Orthopedic |
| 2020-11-19 | K200171 | SMR TT Augmented Glenoid System | PHX | Class II | Orthopedic |
| 2020-07-08 | K200656 | Delta Multihole TT Pro Acetabular System | LPH | Class II | Orthopedic |
| 2020-05-07 | K200653 | AMF Revision TT Cones | JWH | Class II | Orthopedic |
| 2020-01-31 | K193284 | Physica LMC Knee System | JWH | Class II | Orthopedic |