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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 / July 2026 / K261809

510(k) cleared

Interwedge® Standalone Lateral

Foundation Surgical Group · Jul 31, 2026 · K261809

FDA cleared the Interwedge® Standalone Lateral from Foundation Surgical Group on Jul 31, 2026 under K261809, a special 510(k). The device falls under product code OVD, Intervertebral Fusion Device With Integrated Fixation, Lumbar, regulated at 21 CFR 888.3080 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jun 1, 2026. The decision came 60 days later, inside the 90 FDA-day goal for a 510(k).

Foundation Surgical Group has 2 other decisions in the tracker over the last 12 months: K261810 (Vertiwedge® Intraosseous System), K260011 (Foundation Surgical Navigated Lateral Disc Prep Instruments).

Questions & Answers

What did FDA clear under K261809?

K261809 is the FDA 510(k) for Interwedge® Standalone Lateral, submitted by Foundation Surgical Group. FDA's decision date was Jul 31, 2026, under product code OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar).

Who makes the Interwedge® Standalone Lateral?

Foundation Surgical Group, based in Scottsdale, AZ, is the applicant of record for K261809.

How long did the K261809 review take?

FDA received the submission on Jun 1, 2026 and issued its decision on Jul 31, 2026, 60 days later.

← All decisions in July 2026

Sources