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FDA 510(k)

Synchfix EVT

K-Number: K251643 · 2025-10-29

Decision Date2025-10-29
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Synchfix EVT is a medical device manufactured by Wright Medical Technology, Inc. (Stryker Corporation). It received FDA 510(k) clearance on 2025-10-29 under approval number K251643. The device is classified under product code HTN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Synchfix EVT?

Synchfix EVT is a medical device that received FDA 510(k) clearance on 2025-10-29. It is manufactured by Wright Medical Technology, Inc. (Stryker Corporation). The 510(k) number is K251643.

When was Synchfix EVT approved by the FDA?

Synchfix EVT received FDA 510(k) clearance on 2025-10-29, under approval number K251643.

What company makes Synchfix EVT?

Synchfix EVT is manufactured by Wright Medical Technology, Inc. (Stryker Corporation).

What is the FDA product code for Synchfix EVT?

The FDA product code for Synchfix EVT is HTN.

Other Devices by Wright Medical Technology, Inc. (Stryker Corporation)

Related Devices (Code: HTN)

Official Source

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