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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / March 2026 / K253604

510(k) cleared

TiLink-L Navigation Instruments

SurGenTec, LLC · Mar 20, 2026 · K253604

FDA cleared the TiLink-L Navigation Instruments from SurGenTec, LLC on Mar 20, 2026 under K253604, a traditional 510(k). The device falls under product code OLO, Orthopedic Stereotaxic Instrument, regulated at 21 CFR 882.4560 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Nov 18, 2025. The decision came 122 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

SurGenTec, LLC has 4 other decisions in the tracker over the last 12 months: K262121 (Ion-L Navigated Instruments), K261209 (Ion-L), K260329 (Ion-C Navigation Instruments), K251714 (Ion-C).

Questions & Answers

What did FDA clear under K253604?

K253604 is the FDA 510(k) for TiLink-L Navigation Instruments, submitted by SurGenTec, LLC. FDA's decision date was Mar 20, 2026, under product code OLO (Orthopedic Stereotaxic Instrument).

Who makes the TiLink-L Navigation Instruments?

SurGenTec, LLC, based in Boca Raton, FL, is the applicant of record for K253604.

How long did the K253604 review take?

FDA received the submission on Nov 18, 2025 and issued its decision on Mar 20, 2026, 122 days later.

← All decisions in March 2026

Sources