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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 / K260837

510(k) cleared

VersaLift Expandable System

Life Spine, Inc. · May 12, 2026 · K260837

FDA cleared the VersaLift Expandable System from Life Spine, Inc. on May 12, 2026 under K260837, a traditional 510(k). The device falls under product code MAX, Intervertebral Fusion Device With Bone Graft, Lumbar, regulated at 21 CFR 888.3080 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Mar 13, 2026. The decision came 60 days later, inside the 90 FDA-day goal for a 510(k).

Life Spine, Inc. has 4 other decisions in the tracker over the last 12 months: K261430 (TruLift Expandable System), K260571 (SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments), K254274 (ARx® SAI Implant System), K253748 (Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System).

Questions & Answers

What did FDA clear under K260837?

K260837 is the FDA 510(k) for VersaLift Expandable System, submitted by Life Spine, Inc.. FDA's decision date was May 12, 2026, under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar).

Who makes the VersaLift Expandable System?

Life Spine, Inc., based in Huntley, IL, is the applicant of record for K260837.

How long did the K260837 review take?

FDA received the submission on Mar 13, 2026 and issued its decision on May 12, 2026, 60 days later.

← All decisions in May 2026

Sources