Data / Medical devices / United States / Trax Surgical, Inc.
Trax Surgical, Inc.: FDA-registered device maker in Stoughton, MA, United States, 2 510(k) clearances
Trax Surgical, Inc. is registered with the FDA (registration 3026586698) in Stoughton, MA, United States. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 14, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3026586698
- Address
- 75 Mill St, Stoughton, MA, United States, 02072
- Owner or operator
- Trax Surgical, Inc. (10087365)
- Roles
- Manufacturer
- First device listed
- February 16, 2023
- Registered through
- 2026
- Brand names listed
- Linkt
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | 1 | Manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Manufacturer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Manufacturer | accessdata.fda.gov |
| Staple, Fixation, Bone | JDR | 2 | Manufacturer | accessdata.fda.gov |
| Washer, Bolt Nut | HTN | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 14, 2025 | K250712 | Linkt Compression Staple System | JDR | Substantially Equivalent | Trax Surgical | accessdata.fda.gov |
| September 15, 2023 | K230946 | 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 | HWC | Substantially Equivalent | Trax Surgical | accessdata.fda.gov |
Compare with other makers
- All makers of Orthopedic Manual Surgical Instrument
- All makers of Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- All makers of Staple, Fixation, Bone
- All makers of Washer, Bolt Nut
- All makers of Screw, Fixation, Bone
Updated May 14, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.