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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 / K261112

510(k) cleared

CastleLoc-P Anterior Cervical Plate System

L&K BIOMED Co., Ltd. · May 6, 2026 · K261112

FDA cleared the CastleLoc-P Anterior Cervical Plate System from L&K BIOMED Co., Ltd. on May 6, 2026 under K261112, a special 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 Apr 3, 2026. The decision came 33 days later, inside the 90 FDA-day goal for a 510(k).

L&K BIOMED Co., Ltd. has 4 other decisions in the tracker over the last 12 months: K260840 (BluEX Cervical Expandable Cage System), K261130 (AccelFix Spinal Fixation System), K260448 (CastleLoc Pectus Bar System), K251940 (PathLoc Lumbar Plate System).

Questions & Answers

What did FDA clear under K261112?

K261112 is the FDA 510(k) for CastleLoc-P Anterior Cervical Plate System, submitted by L&K BIOMED Co., Ltd.. FDA's decision date was May 6, 2026, under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body).

Who makes the CastleLoc-P Anterior Cervical Plate System?

L&K BIOMED Co., Ltd., based in Yongin-Si, is the applicant of record for K261112.

How long did the K261112 review take?

FDA received the submission on Apr 3, 2026 and issued its decision on May 6, 2026, 33 days later.

← All decisions in May 2026

Sources