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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 / K250764

510(k) cleared

SpineLinc Anterior Cervical Implant System

Lincotek Medical · Dec 5, 2025 · K250764

FDA cleared the SpineLinc Anterior Cervical Implant System from Lincotek Medical on Dec 5, 2025 under K250764, 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 Mar 13, 2025. The decision came 267 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Lincotek Medical has one other decision in the tracker over the last 12 months: K252081 (SportLinc Syndesmosis Device).

Questions & Answers

What did FDA clear under K250764?

K250764 is the FDA 510(k) for SpineLinc Anterior Cervical Implant System, submitted by Lincotek Medical. FDA's decision date was Dec 5, 2025, under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical).

Who makes the SpineLinc Anterior Cervical Implant System?

Lincotek Medical, based in Bartlett, TN, is the applicant of record for K250764.

How long did the K250764 review take?

FDA received the submission on Mar 13, 2025 and issued its decision on Dec 5, 2025, 267 days later.

← All decisions in December 2025

Sources