Stryker GmbH
FDA 510(k) & PMA Approved Devices — 53 products
Total Devices53
Categories9
Latest FDA decision2026-06-29
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K261481 | Pangea Femur Reconstruction System | HSB | 2026-06-29 | View |
| 510(k) | K253640 | T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System | HSB | 2026-02-03 | View |
| 510(k) | K253202 | Hoffmann LRF System | KTT | 2025-12-19 | View |
| 510(k) | K251400 | T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System | HSB | 2025-08-20 | View |
| 510(k) | K250163 | T2 Alpha Femur Retrograde Nailing System | HSB | 2025-08-13 | View |
| 510(k) | K242445 | Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System | HRS | 2024-10-06 | View |
| 510(k) | K233919 | VariAx 2 Distal Radius System | HRS | 2024-03-25 | View |
| 510(k) | K233741 | Hoffmann LRF System | KTT | 2023-12-21 | View |
| 510(k) | K231257 | Pangea Utility Plating System, Pangea Platform | HRS | 2023-08-18 | View |
| 510(k) | K231262 | Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System | HRS | 2023-08-18 | View |
| 510(k) | K230512 | Gamma4 System | HSB | 2023-06-09 | View |
| 510(k) | K222381 | PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System | HRS | 2023-04-27 | View |
| 510(k) | K223772 | PRO Plating System, Stryker Trauma Pelvic Set (Matta) | HRS | 2023-04-07 | View |
| 510(k) | K222309 | Gamma4 System | HSB | 2022-11-15 | View |
| 510(k) | K221346 | Stryker VariAx 2 MIS Calcaneus | HRS | 2022-07-08 | View |
| 510(k) | K210582 | EasyClip® and EasyClip® Xpress | JDR | 2022-06-10 | View |
| 510(k) | K220319 | Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw System | HWC | 2022-06-10 | View |
| 510(k) | K213328 | Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System | HSB | 2022-02-11 | View |
| 510(k) | K212581 | VariAx 2 Distal Radius System, VariAx 2 Distal Ulna System | HRS | 2022-01-19 | View |
| 510(k) | K213199 | Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System | HWC | 2022-01-11 | View |
No matching devices.
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