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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 / April 2026 / K260011

510(k) cleared

Foundation Surgical Navigated Lateral Disc Prep Instruments

Foundation Surgical Group, Inc. · Apr 16, 2026 · K260011

FDA cleared the Foundation Surgical Navigated Lateral Disc Prep Instruments from Foundation Surgical Group, Inc. on Apr 16, 2026 under K260011, 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 Jan 2, 2026. The decision came 104 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Foundation Surgical Group, Inc. has 2 other decisions in the tracker over the last 12 months: K261809 (Interwedge® Standalone Lateral), K261810 (Vertiwedge® Intraosseous System).

Questions & Answers

What did FDA clear under K260011?

K260011 is the FDA 510(k) for Foundation Surgical Navigated Lateral Disc Prep Instruments, submitted by Foundation Surgical Group, Inc.. FDA's decision date was Apr 16, 2026, under product code OLO (Orthopedic Stereotaxic Instrument).

Who makes the Foundation Surgical Navigated Lateral Disc Prep Instruments?

Foundation Surgical Group, Inc., based in Scottsdale, AZ, is the applicant of record for K260011.

How long did the K260011 review take?

FDA received the submission on Jan 2, 2026 and issued its decision on Apr 16, 2026, 104 days later.

← All decisions in April 2026

Sources