Medical Device Manufacturer · CH , Selzach, Solothurn, Ch

Stryker GmbH

54 submissions · 54 cleared · Since 2015
54
Total
54
Cleared
0
Denied

Stryker GmbH — FDA 510(k) Submissions

Stryker GmbH has submitted 54 FDA 510(k) premarket notifications since 2015, of which 54 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Plate, Fixation, Bone, Rod, Fixation, Intramedullary And Accessories, Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Screw, Fixation, Bone, Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented . Use the specialty filter in the sidebar to narrow results.

54 devices
1–25 of 54
T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System
K253640 · HSB Rod, Fixation,... · Orthopedic
Feb 2026 76d
Hoffmann LRF System
K253202 · KTT Appliance, Fixation,... · Orthopedic
Dec 2025 84d
T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System
K251400 · HSB Rod, Fixation,... · Orthopedic
Aug 2025 106d
T2 Alpha Femur Retrograde Nailing System
K250163 · HSB Rod, Fixation,... · Orthopedic
Aug 2025 204d
Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System
K242445 · HRS Plate, Fixation, Bone · Orthopedic
Oct 2024 51d
VariAx 2 Distal Radius System
K233919 · HRS Plate, Fixation, Bone · Orthopedic
Mar 2024 103d
Hoffmann LRF System
K233741 · KTT Appliance, Fixation,... · Orthopedic
Dec 2023 29d
Pangea Utility Plating System, Pangea Platform
K231257 · HRS Plate, Fixation, Bone · Orthopedic
Aug 2023 109d
Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System
K231262 · HRS Plate, Fixation, Bone · Orthopedic
Aug 2023 109d
Gamma4 System
K230512 · HSB Rod, Fixation,... · Orthopedic
Jun 2023 105d
PeriPRO? Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System
K222381 · HRS Plate, Fixation, Bone · Orthopedic
Apr 2023 265d
PRO Plating System, Stryker Trauma Pelvic Set (Matta)
K223772 · HRS Plate, Fixation, Bone · Orthopedic
Apr 2023 112d
Gamma4 System
K222309 · HSB Rod, Fixation,... · Orthopedic
Nov 2022 106d
Stryker VariAx 2 MIS Calcaneus
K221346 · HRS Plate, Fixation, Bone · Orthopedic
Jul 2022 60d
EasyClip? and EasyClip? Xpress
K210582 · JDR Staple, Fixation, Bone · Orthopedic
Jun 2022 469d
Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw System
K220319 · HWC Screw, Fixation, Bone · Orthopedic
Jun 2022 127d
Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System
K213328 · HSB Rod, Fixation,... · Orthopedic
Feb 2022 129d
VariAx 2 Distal Radius System, VariAx 2 Distal Ulna System
K212581 · HRS Plate, Fixation, Bone · Orthopedic
Jan 2022 156d
Asnis? III Cannulated Screw System and Asnis? PRO Cannulated Screw System
K213199 · HWC Screw, Fixation, Bone · Orthopedic
Jan 2022 104d
Steinmann Pins and Kirschner Wires
K211508 · JDW Pin, Fixation, Threaded · Orthopedic
Oct 2021 144d
ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
K210861 · KWS Prosthesis, Shoulder,... · Orthopedic
Sep 2021 164d
T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Tibial Nailing System, T2 Femoral System, T2 Supracondylar Nail System
K203819 · HSB Rod, Fixation,... · Orthopedic
Feb 2021 59d
Hoffmann LRF System
K203568 · KTT Appliance, Fixation,... · Orthopedic
Feb 2021 56d
ADAPT for Gamma3
K202749 · OLO Orthopedic Stereotaxic... · Orthopedic
Dec 2020 88d
ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
K202289 · KWS Prosthesis, Shoulder,... · Orthopedic
Dec 2020 126d
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