Medical Device Manufacturer · US , Stoughton , MA

Trax Surgical

2 submissions · 2 cleared · Since 2023

Total

Cleared

Denied

Trax Surgical — FDA 510(k) Submissions

Trax Surgical has submitted 2 FDA 510(k) premarket notifications since 2023, of which 2 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Staple, Fixation, Bone, Screw, Fixation, Bone . Use the specialty filter in the sidebar to narrow results.

2 devices

1–2 of 2

Linkt Compression Staple System

K250712 · JDR Staple, Fixation, Bone · Orthopedic

May 2025 65d

Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression Screw System-Medium Product Code ACC-M; Accelerate Compression Screw System-Large Product Code ACC-L

K230946 · HWC Screw, Fixation, Bone · Orthopedic

Sep 2023 164d

Data Source

FDA 510(k) public files . 174,402 total devices indexed.

Trax Surgical

Trax Surgical — FDA 510(k) Submissions

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