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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 / July 2026 / K261129

510(k) cleared

OrthoFit

Spident Co., Ltd. · Jul 2, 2026 · K261129

FDA cleared the OrthoFit from Spident Co., Ltd. on Jul 2, 2026 under K261129, a traditional 510(k). The device falls under product code DYH, Adhesive, Bracket And Tooth Conditioner, Resin, regulated at 21 CFR 872.3750 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Apr 6, 2026. The decision came 87 days later, inside the 90 FDA-day goal for a 510(k).

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

Questions & Answers

What did FDA clear under K261129?

K261129 is the FDA 510(k) for OrthoFit, submitted by Spident Co., Ltd.. FDA's decision date was Jul 2, 2026, under product code DYH (Adhesive, Bracket And Tooth Conditioner, Resin).

Who makes the OrthoFit?

Spident Co., Ltd., based in Incheon, is the applicant of record for K261129.

How long did the K261129 review take?

FDA received the submission on Apr 6, 2026 and issued its decision on Jul 2, 2026, 87 days later.

← All decisions in July 2026