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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 / August 2026 / K260277

510(k) cleared

MIKRON TRAUMA BONE PLATE& SCREW SYSTEM

Mikron Makina San. ve Tic. Ltd. Sti. · Aug 13, 2026 · K260277

FDA cleared the MIKRON TRAUMA BONE PLATE& SCREW SYSTEM from Mikron Makina San. ve Tic. Ltd. Sti. on Aug 13, 2026 under K260277, a traditional 510(k). The device falls under product code HRS, Plate, Fixation, Bone, regulated at 21 CFR 888.3030 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jan 29, 2026. The decision came 196 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Mikron Makina San. ve Tic. Ltd. Sti. has one other decision in the tracker over the last 12 months: K252781 (MSFX MIKRON PEEK CAGES).

Questions & Answers

What did FDA clear under K260277?

K260277 is the FDA 510(k) for MIKRON TRAUMA BONE PLATE& SCREW SYSTEM, submitted by Mikron Makina San. ve Tic. Ltd. Sti.. FDA's decision date was Aug 13, 2026, under product code HRS (Plate, Fixation, Bone).

Who makes the MIKRON TRAUMA BONE PLATE& SCREW SYSTEM?

Mikron Makina San. ve Tic. Ltd. Sti., based in Yenimahalle, is the applicant of record for K260277.

How long did the K260277 review take?

FDA received the submission on Jan 29, 2026 and issued its decision on Aug 13, 2026, 196 days later.

← All decisions in August 2026

Sources