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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 / June 2026 / K251251

510(k) cleared

ChanPin Pedicle Screw Spinal System

Chanpin Medtak Co., Ltd. · Jun 9, 2026 · K251251

FDA cleared the ChanPin Pedicle Screw Spinal System from Chanpin Medtak Co., Ltd. on Jun 9, 2026 under K251251, a traditional 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 23, 2025. The decision came 412 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Chanpin Medtak Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251251?

K251251 is the FDA 510(k) for ChanPin Pedicle Screw Spinal System, submitted by Chanpin Medtak Co., Ltd.. FDA's decision date was Jun 9, 2026, under product code NKB (Thoracolumbosacral Pedicle Screw System).

Who makes the ChanPin Pedicle Screw Spinal System?

Chanpin Medtak Co., Ltd., based in New Taipei City, is the applicant of record for K251251.

How long did the K251251 review take?

FDA received the submission on Apr 23, 2025 and issued its decision on Jun 9, 2026, 412 days later.

← All decisions in June 2026