510(k) K251643

Synchfix EVT by Wright Medical Technology, Inc. (Stryker Corporation) — Product Code HTN

K251643 is an FDA 510(k) premarket notification submitted by Wright Medical Technology, Inc. (Stryker Corporation) for the device "Synchfix EVT". The FDA issued a decision of Substantially Equivalent on October 29, 2025. The device falls under product code HTN (Washer, Bolt Nut), a Class II device regulated under 21 CFR 888.3030. Wright Medical Technology, Inc. (Stryker Corporation) has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 2025
Date Received
May 29, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Washer, Bolt Nut
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type