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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 / March 2026 / K251940

510(k) cleared

PathLoc Lumbar Plate System

L&K BIOMED Co., Ltd. · Mar 3, 2026 · K251940

FDA cleared the PathLoc Lumbar Plate System from L&K BIOMED Co., Ltd. on Mar 3, 2026 under K251940, a traditional 510(k). The device falls under product code KWQ, Appliance, Fixation, Spinal Intervertebral Body, regulated at 21 CFR 888.3060 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jun 24, 2025. The decision came 252 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

L&K BIOMED Co., Ltd. has 4 other decisions in the tracker over the last 12 months: K260840 (BluEX Cervical Expandable Cage System), K261112 (CastleLoc-P Anterior Cervical Plate System), K261130 (AccelFix Spinal Fixation System), K260448 (CastleLoc Pectus Bar System).

Questions & Answers

What did FDA clear under K251940?

K251940 is the FDA 510(k) for PathLoc Lumbar Plate System, submitted by L&K BIOMED Co., Ltd.. FDA's decision date was Mar 3, 2026, under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body).

Who makes the PathLoc Lumbar Plate System?

L&K BIOMED Co., Ltd., based in Yongin-Si, is the applicant of record for K251940.

How long did the K251940 review take?

FDA received the submission on Jun 24, 2025 and issued its decision on Mar 3, 2026, 252 days later.

← All decisions in March 2026

Sources