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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 / K261154

510(k) cleared

CoLink® & CoLag® Non-Sterile Screws

In2Bones USA, LLC · May 30, 2026 · K261154

FDA cleared the CoLink® & CoLag® Non-Sterile Screws from In2Bones USA, LLC on May 30, 2026 under K261154, a special 510(k). The device falls under product code HWC, Screw, Fixation, Bone, regulated at 21 CFR 888.3040 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Apr 8, 2026. The decision came 52 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for In2Bones USA, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261154?

K261154 is the FDA 510(k) for CoLink® & CoLag® Non-Sterile Screws, submitted by In2Bones USA, LLC. FDA's decision date was May 30, 2026, under product code HWC (Screw, Fixation, Bone).

Who makes the CoLink® & CoLag® Non-Sterile Screws?

In2Bones USA, LLC, based in Cordova, TN, is the applicant of record for K261154.

How long did the K261154 review take?

FDA received the submission on Apr 8, 2026 and issued its decision on May 30, 2026, 52 days later.

← All decisions in May 2026