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FDA 510(k)

Synchfix EVT

K-Number: K251643 · 2025-10-29

ApplicantWright Medical Technology, Inc. (Stryker Corporation)
Decision Date2025-10-29
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Synchfix EVT is the device name listed in this FDA 510(k) record. The listed applicant is Wright Medical Technology, Inc. (Stryker Corporation). It received FDA 510(k) clearance on 2025-10-29 under 510(k) 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. The listed applicant is Wright Medical Technology, Inc. (Stryker Corporation). The 510(k) number is K251643.

When did Synchfix EVT receive FDA 510(k) clearance?

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

Who is the listed applicant for Synchfix EVT?

The FDA 510(k) record lists Wright Medical Technology, Inc. (Stryker Corporation) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Synchfix EVT?

The FDA product code for Synchfix EVT is HTN.

Other records listing Wright Medical Technology, Inc. (Stryker Corporation) as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: HTN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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