FDA 510(k)

SportLinc Syndesmosis Device

K-Number: K252081 · 2026-03-27

Decision Date2026-03-27

Product CodeHTN

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

SportLinc Syndesmosis Device is the device name listed in this FDA 510(k) record. The listed applicant is Lincotek Medical. It received FDA 510(k) clearance on 2026-03-27 under 510(k) number K252081. 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 SportLinc Syndesmosis Device?

SportLinc Syndesmosis Device is a medical device that received FDA 510(k) clearance on 2026-03-27. The listed applicant is Lincotek Medical. The 510(k) number is K252081.

When did SportLinc Syndesmosis Device receive FDA 510(k) clearance?

SportLinc Syndesmosis Device received FDA 510(k) clearance on 2026-03-27, under 510(k) number K252081.

Who is the listed applicant for SportLinc Syndesmosis Device?

The FDA 510(k) record lists Lincotek Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SportLinc Syndesmosis Device?

The FDA product code for SportLinc Syndesmosis Device is HTN.

Other records listing Lincotek Medical 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.

K250764SpineLinc Anterior Cervical Implant System

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K253115LARS ACJMovmedix S.A.S.K253727Syndesmosis TightRope PROArthrex, Inc.K251643Synchfix EVTWright Medical Technology, Inc. (Stryker Corporation)K251134RipCordTriMed, Inc.K243624Acu-Sinch Knotless MiniAcumed, LLC K242091Bolo Button SystemFusion Orthopedics

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.