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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 / May 2026 / K261060

510(k) cleared

Navigated LLIF Impactable Tracker

Tyber Medical, LLC · May 29, 2026 · K261060

FDA cleared the Navigated LLIF Impactable Tracker from Tyber Medical, LLC on May 29, 2026 under K261060, 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 Mar 31, 2026. The decision came 59 days later, inside the 90 FDA-day goal for a 510(k).

Tyber Medical, LLC has 5 other decisions in the tracker over the last 12 months: K261207 (Exalta Proximal Tibia Plating System), K260810 (Anteralign LS coverplate), K253042 (Tyber Medical Trauma Screw), K252901 (Tyber Medical Trauma Screw).

Questions & Answers

What did FDA clear under K261060?

K261060 is the FDA 510(k) for Navigated LLIF Impactable Tracker, submitted by Tyber Medical, LLC. FDA's decision date was May 29, 2026, under product code OLO (Orthopedic Stereotaxic Instrument).

Who makes the Navigated LLIF Impactable Tracker?

Tyber Medical, LLC, based in Bethlehem, PA, is the applicant of record for K261060.

How long did the K261060 review take?

FDA received the submission on Mar 31, 2026 and issued its decision on May 29, 2026, 59 days later.

← All decisions in May 2026

Sources