Cleared Traditional

Synchfix EVT

K251643 · Wright Medical Technology, Inc. (Stryker Corporation) · Orthopedic
Oct 2025
Decision
153d
Days
Class 2
Risk

About This 510(k) Submission

K251643 is an FDA 510(k) clearance for the Synchfix EVT, a Washer, Bolt Nut (Class II — Special Controls, product code HTN), submitted by Wright Medical Technology, Inc. (Stryker Corporation) (Memphis, US). The FDA issued a Cleared decision on October 29, 2025, 153 days after receiving the submission on May 29, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K251643 FDA.gov
FDA Decision Cleared SESE
Date Received May 29, 2025
Decision Date October 29, 2025
Days to Decision 153 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HTN — Washer, Bolt Nut
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030