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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 / June 2026 / K252982

510(k) cleared

CONDUIT ZERO-P VA Secured Spacer System

Avalign Technologies, Inc. · Jun 18, 2026 · K252982

FDA cleared the CONDUIT ZERO-P VA Secured Spacer System from Avalign Technologies, Inc. on Jun 18, 2026 under K252982, a traditional 510(k). The device falls under product code OVE, Intervertebral Fusion Device With Integrated Fixation, 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 17, 2025. The decision came 274 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 Avalign Technologies, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252982?

K252982 is the FDA 510(k) for CONDUIT ZERO-P VA Secured Spacer System, submitted by Avalign Technologies, Inc.. FDA's decision date was Jun 18, 2026, under product code OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical).

Who makes the CONDUIT ZERO-P VA Secured Spacer System?

Avalign Technologies, Inc., based in Fort Wayne, IN, is the applicant of record for K252982.

How long did the K252982 review take?

FDA received the submission on Sep 17, 2025 and issued its decision on Jun 18, 2026, 274 days later.

← All decisions in June 2026