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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 / January 2026 / K253748

510(k) cleared

Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System

Life Spine, Inc. · Jan 23, 2026 · K253748

FDA cleared the Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System from Life Spine, Inc. on Jan 23, 2026 under K253748, 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 Nov 25, 2025. The decision came 59 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), K260837 (VersaLift Expandable System), K254274 (ARx® SAI Implant System).

Questions & Answers

What did FDA clear under K253748?

K253748 is the FDA 510(k) for Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System, submitted by Life Spine, Inc.. FDA's decision date was Jan 23, 2026, under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar).

Who makes the Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System?

Life Spine, Inc., based in Huntley, IL, is the applicant of record for K253748.

How long did the K253748 review take?

FDA received the submission on Nov 25, 2025 and issued its decision on Jan 23, 2026, 59 days later.

← All decisions in January 2026

Sources