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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 / October 2025 / K250520

510(k) cleared

OsteoCentric Navigated Instruments System

Osteocentric Technologies, Inc. · Oct 27, 2025 · K250520

FDA cleared the OsteoCentric Navigated Instruments System from Osteocentric Technologies, Inc. on Oct 27, 2025 under K250520, a traditional 510(k). The device falls under product code OLO, Orthopedic Stereotaxic Instrument, regulated at 21 CFR 882.4560 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Feb 21, 2025. The decision came 248 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 Osteocentric Technologies, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250520?

K250520 is the FDA 510(k) for OsteoCentric Navigated Instruments System, submitted by Osteocentric Technologies, Inc.. FDA's decision date was Oct 27, 2025, under product code OLO (Orthopedic Stereotaxic Instrument).

Who makes the OsteoCentric Navigated Instruments System?

Osteocentric Technologies, Inc., based in Logan, UT, is the applicant of record for K250520.

How long did the K250520 review take?

FDA received the submission on Feb 21, 2025 and issued its decision on Oct 27, 2025, 248 days later.

← All decisions in October 2025