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THE TAPE

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 / K261430

510(k) cleared

TruLift Expandable System

Life Spine, Inc. · Jul 28, 2026 · K261430

FDA cleared the TruLift Expandable System from Life Spine, Inc. on Jul 28, 2026 under K261430, 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 Apr 30, 2026. The decision came 89 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: K260571 (SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments), K260837 (VersaLift Expandable System), 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 K261430?

K261430 is the FDA 510(k) for TruLift Expandable System, submitted by Life Spine, Inc.. FDA's decision date was Jul 28, 2026, under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar).

Who makes the TruLift Expandable System?

Life Spine, Inc., based in Huntley, IL, is the applicant of record for K261430.

How long did the K261430 review take?

FDA received the submission on Apr 30, 2026 and issued its decision on Jul 28, 2026, 89 days later.

← All decisions in July 2026

Sources