TiLink-L Navigation Instruments
K-Number: K253604 · 2026-03-20
ApplicantSurGenTec, LLC
Decision Date2026-03-20
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
TiLink-L Navigation Instruments is a medical device manufactured by SurGenTec, LLC. It received FDA 510(k) clearance on 2026-03-20 under approval number K253604. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TiLink-L Navigation Instruments?
TiLink-L Navigation Instruments is a medical device that received FDA 510(k) clearance on 2026-03-20. It is manufactured by SurGenTec, LLC. The 510(k) number is K253604.
When was TiLink-L Navigation Instruments approved by the FDA?
TiLink-L Navigation Instruments received FDA 510(k) clearance on 2026-03-20, under approval number K253604.
What company makes TiLink-L Navigation Instruments?
TiLink-L Navigation Instruments is manufactured by SurGenTec, LLC.
What is the FDA product code for TiLink-L Navigation Instruments?
The FDA product code for TiLink-L Navigation Instruments is OLO.
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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.