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Tiger Track Screw System

by Synchro Medical 510(k)

Active United States

510(k) K151241

Overview

The Tiger Track Screw System is a metallic bone fixation device classified under 21 CFR 888.3040 as a smooth or threaded bone fastener. It is designed for internal fixation of long bone fractures, including corrective osteotomies, pseudoarthrosis, and degenerative transformations in the hind foot and intra-articular fractures of the humerus, femur, and tibia. The system provides secure stabilization through precise screw placement within bone structures.

Available in 4.5 mm and 7.0 mm diameters, the system is intended for single-use applications in orthopedic surgery. It is supplied sterile and regulated under FDA 510(k) clearance (K151241), with a Substantially Equivalent (SESE) determination by the Orthopedic (OR) Advisory Committee. Storage and handling follow standard sterile orthopedic implant protocols to ensure integrity before surgical use.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK151241 Date7 Aug 2015ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

Full name
Synchro-Medical TIGER TRACK Screw System
510(k) Number
FDA Product Code
HWC
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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