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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 / K260546

510(k) cleared

Q Pedicle Instruments

K2m, Inc. · Mar 17, 2026 · K260546

FDA cleared the Q Pedicle Instruments from K2m, Inc. on Mar 17, 2026 under K260546, a special 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 Feb 18, 2026. The decision came 27 days later, inside the 90 FDA-day goal for a 510(k).

K2m, Inc. has 2 other decisions in the tracker over the last 12 months: K253545 (Vulcan Spinal System), K252873 (Q Interbody Instruments).

Questions & Answers

What did FDA clear under K260546?

K260546 is the FDA 510(k) for Q Pedicle Instruments, submitted by K2m, Inc.. FDA's decision date was Mar 17, 2026, under product code OLO (Orthopedic Stereotaxic Instrument).

Who makes the Q Pedicle Instruments?

K2m, Inc., based in Leesburg, VA, is the applicant of record for K260546.

How long did the K260546 review take?

FDA received the submission on Feb 18, 2026 and issued its decision on Mar 17, 2026, 27 days later.

← All decisions in March 2026

Sources