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Stryker GmbH FDA Approvals
0 new drug approvals and 24 device clearances on file. Matched by name to SYK.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| Pangea Femur Reconstruction System510(k)Jun 29, 2026Orthopedic |
| T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System510(k)Feb 3, 2026Orthopedic |
| Hoffmann LRF System510(k)Dec 19, 2025Orthopedic |
| T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System510(k)Aug 20, 2025Orthopedic |
| T2 Alpha Femur Retrograde Nailing System510(k)Aug 13, 2025Orthopedic |
| Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System510(k)Oct 6, 2024Orthopedic |
| VariAx 2 Distal Radius System510(k)Mar 25, 2024Orthopedic |
| Hoffmann LRF System510(k)Dec 21, 2023Orthopedic |
| Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System510(k)Aug 18, 2023Orthopedic |
| Pangea Utility Plating System, Pangea Platform510(k)Aug 18, 2023Orthopedic |
| Gamma4 System510(k)Jun 9, 2023Orthopedic |
| PeriPRO Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System510(k)Apr 27, 2023Orthopedic |
| PRO Plating System, Stryker Trauma Pelvic Set (Matta)510(k)Apr 7, 2023Orthopedic |
| Gamma4 System510(k)Nov 15, 2022Orthopedic |
| Stryker VariAx 2 MIS Calcaneus510(k)Jul 8, 2022Orthopedic |
| EasyClip® and EasyClip® Xpress510(k)Jun 10, 2022Orthopedic |
| Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw System510(k)Jun 10, 2022Orthopedic |
| Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System510(k)Feb 11, 2022Orthopedic |
| VariAx 2 Distal Radius System, VariAx 2 Distal Ulna System510(k)Jan 19, 2022Orthopedic |
| Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System510(k)Jan 11, 2022Orthopedic |
| Steinmann Pins and Kirschner Wires510(k)Oct 5, 2021Orthopedic |
| ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)510(k)Sep 3, 2021Orthopedic |
| T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Tibial Nailing System, T2 Femoral System, T2 Supracondylar Nail System510(k)Feb 26, 2021Orthopedic |
| Hoffmann LRF System510(k)Feb 1, 2021Orthopedic |