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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 / February 2026 / K252873

510(k) cleared

Q Interbody Instruments

K2m, Inc. · Feb 6, 2026 · K252873

FDA cleared the Q Interbody Instruments from K2m, Inc. on Feb 6, 2026 under K252873, 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 Sep 10, 2025. The decision came 149 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

K2m, Inc. has 2 other decisions in the tracker over the last 12 months: K260546 (Q Pedicle Instruments), K253545 (Vulcan Spinal System).

Questions & Answers

What did FDA clear under K252873?

K252873 is the FDA 510(k) for Q Interbody Instruments, submitted by K2m, Inc.. FDA's decision date was Feb 6, 2026, under product code OLO (Orthopedic Stereotaxic Instrument).

Who makes the Q Interbody Instruments?

K2m, Inc., based in Leesburg, VA, is the applicant of record for K252873.

How long did the K252873 review take?

FDA received the submission on Sep 10, 2025 and issued its decision on Feb 6, 2026, 149 days later.

← All decisions in February 2026

Sources