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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 / December 2025 / K252781

510(k) cleared

MSFX MIKRON PEEK CAGES

Mikron Makina Sanayi VE Tic. Ltd. Sti. · Dec 19, 2025 · K252781

FDA cleared the MSFX MIKRON PEEK CAGES from Mikron Makina Sanayi VE Tic. Ltd. Sti. on Dec 19, 2025 under K252781, a traditional 510(k). The device falls under product code ODP, Intervertebral Fusion Device With Bone Graft, Cervical, regulated at 21 CFR 888.3080 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Sep 2, 2025. The decision came 108 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Mikron Makina Sanayi VE Tic. Ltd. Sti. has one other decision in the tracker over the last 12 months: K260277 (MIKRON TRAUMA BONE PLATE& SCREW SYSTEM).

Questions & Answers

What did FDA clear under K252781?

K252781 is the FDA 510(k) for MSFX MIKRON PEEK CAGES, submitted by Mikron Makina Sanayi VE Tic. Ltd. Sti.. FDA's decision date was Dec 19, 2025, under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical).

Who makes the MSFX MIKRON PEEK CAGES?

Mikron Makina Sanayi VE Tic. Ltd. Sti., based in Yenimahalle, is the applicant of record for K252781.

How long did the K252781 review take?

FDA received the submission on Sep 2, 2025 and issued its decision on Dec 19, 2025, 108 days later.

← All decisions in December 2025

Sources