SportLinc Syndesmosis Device
K-Number: K252081 · 2026-03-27
ApplicantLincotek Medical
Decision Date2026-03-27
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
SportLinc Syndesmosis Device is a medical device manufactured by Lincotek Medical. It received FDA 510(k) clearance on 2026-03-27 under approval 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. It is manufactured by Lincotek Medical. The 510(k) number is K252081.
When was SportLinc Syndesmosis Device approved by the FDA?
SportLinc Syndesmosis Device received FDA 510(k) clearance on 2026-03-27, under approval number K252081.
What company makes SportLinc Syndesmosis Device?
SportLinc Syndesmosis Device is manufactured by Lincotek Medical.
What is the FDA product code for SportLinc Syndesmosis Device?
The FDA product code for SportLinc Syndesmosis Device is HTN.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.