Trax Surgical, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
1
Total
1
Cleared
0
Denied
Trax Surgical, Inc. manufactures bone compression tools and surgical instrumentation for extremity procedures. The company specializes in headed and headless compression bone screws, snap-away bone screws, instrumentation kits, and nitinol compression staples. Operations are based in Stoughton, Massachusetts, at an FDA-registered facility certified to ISO 13485:2016.
Trax Surgical has received 1 FDA 510(k) clearance from 1 total submission. The company's focus is entirely on Orthopedic devices for internal fixation, reconstruction, and fracture repair. The most recent clearance was in 2026, reflecting active regulatory engagement.
The company's product portfolio includes the Trax EX Anchor for soft tissue reattachment and the LINKT™ Compression Staple System, engineered with shape-memory alloy properties for continuous compression in bone fusion procedures. All products are designed for upper and lower extremity applications, including osteotomy, fixation, fusion, and trauma surgery.
Explore the complete regulatory record, including device names, product codes, and clearance dates in the FDA 510(k) database.
FDA 510(k) Regulatory Record - Trax Surgical, Inc.
1 devices