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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 / January 2026 / K252711

510(k) cleared

Advantage-C Ti3D Cervical Interbody Fusion Device

Intelivation Technologies · Jan 8, 2026 · K252711

FDA cleared the Advantage-C Ti3D Cervical Interbody Fusion Device from Intelivation Technologies on Jan 8, 2026 under K252711, 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 Aug 27, 2025. The decision came 134 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 Intelivation Technologies in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252711?

K252711 is the FDA 510(k) for Advantage-C Ti3D Cervical Interbody Fusion Device, submitted by Intelivation Technologies. FDA's decision date was Jan 8, 2026, under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical).

Who makes the Advantage-C Ti3D Cervical Interbody Fusion Device?

Intelivation Technologies, based in Plymouth Meeting, PA, is the applicant of record for K252711.

How long did the K252711 review take?

FDA received the submission on Aug 27, 2025 and issued its decision on Jan 8, 2026, 134 days later.

← All decisions in January 2026