Stryker GmbH - FDA 510(k) Cleared Devices
Recent clearances: T2 Alpha Femur Retrograde Nailing System, Hoffmann LRF System, T2 Alpha Humerus Nailing System
54
Total
54
Cleared
0
Denied
FDA 510(k) Regulatory Record - Stryker GmbH Orthopedic ✕
54 devices
Cleared
Feb 03, 2026
T2 Alpha Femur Retrograde Nailing System
Orthopedic
76d
Cleared
Dec 19, 2025
Hoffmann LRF System
Orthopedic
84d
Cleared
Aug 20, 2025
T2 Alpha Humerus Nailing System
Orthopedic
106d
Cleared
Aug 13, 2025
T2 Alpha Femur Retrograde Nailing System
Orthopedic
204d
Cleared
Oct 06, 2024
Pangea Platform
Orthopedic
51d
Cleared
Mar 25, 2024
VariAx 2 Distal Radius System
Orthopedic
103d
Cleared
Dec 21, 2023
Hoffmann LRF System
Orthopedic
29d
Cleared
Aug 18, 2023
Pangea Utility Plating System, Pangea Platform
Orthopedic
109d
Cleared
Aug 18, 2023
Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia...
Orthopedic
109d
Cleared
Jun 09, 2023
Gamma4 System
Orthopedic
105d
Cleared
Apr 27, 2023
PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker...
Orthopedic
265d
Cleared
Apr 07, 2023
PRO Plating System, Stryker Trauma Pelvic Set (Matta)
Orthopedic
112d
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