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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 / September 2025 / K250123

510(k) cleared

Master-Pin X (MP Pin with thread) (36BMP000030 / MP30)

Hager& Meisinger GmbH · Sep 29, 2025 · K250123

FDA cleared the Master-Pin X (MP Pin with thread) (36BMP000030 / MP30) from Hager& Meisinger GmbH on Sep 29, 2025 under K250123, a traditional 510(k). The device falls under product code DZL, Screw, Fixation, Intraosseous, regulated at 21 CFR 872.4880 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Jan 17, 2025. The decision came 255 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 Hager& Meisinger GmbH in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250123?

K250123 is the FDA 510(k) for Master-Pin X (MP Pin with thread) (36BMP000030 / MP30), submitted by Hager& Meisinger GmbH. FDA's decision date was Sep 29, 2025, under product code DZL (Screw, Fixation, Intraosseous).

Who makes the Master-Pin X (MP Pin with thread) (36BMP000030 / MP30)?

Hager& Meisinger GmbH, based in Neuss, is the applicant of record for K250123.

How long did the K250123 review take?

FDA received the submission on Jan 17, 2025 and issued its decision on Sep 29, 2025, 255 days later.

← All decisions in September 2025