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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 / K261130

510(k) cleared

AccelFix Spinal Fixation System

L&K BIOMED Co., Ltd. · May 5, 2026 · K261130

FDA cleared the AccelFix Spinal Fixation System from L&K BIOMED Co., Ltd. on May 5, 2026 under K261130, a special 510(k). The device falls under product code NKB, Thoracolumbosacral Pedicle Screw System, regulated at 21 CFR 888.3070 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Apr 6, 2026. The decision came 29 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), K261112 (CastleLoc-P Anterior Cervical Plate System), K260448 (CastleLoc Pectus Bar System), K251940 (PathLoc Lumbar Plate System).

Questions & Answers

What did FDA clear under K261130?

K261130 is the FDA 510(k) for AccelFix Spinal Fixation System, submitted by L&K BIOMED Co., Ltd.. FDA's decision date was May 5, 2026, under product code NKB (Thoracolumbosacral Pedicle Screw System).

Who makes the AccelFix Spinal Fixation System?

L&K BIOMED Co., Ltd., based in Yongin-Si, is the applicant of record for K261130.

How long did the K261130 review take?

FDA received the submission on Apr 6, 2026 and issued its decision on May 5, 2026, 29 days later.

← All decisions in May 2026

Sources