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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 / K252219

510(k) cleared

Cervical Interbody and VBR Fusion System

Sync Surgical · Jan 14, 2026 · K252219

FDA cleared the Cervical Interbody and VBR Fusion System from Sync Surgical on Jan 14, 2026 under K252219, 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 Jul 15, 2025. The decision came 183 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 Sync Surgical in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252219?

K252219 is the FDA 510(k) for Cervical Interbody and VBR Fusion System, submitted by Sync Surgical. FDA's decision date was Jan 14, 2026, under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical).

Who makes the Cervical Interbody and VBR Fusion System?

Sync Surgical, based in Plano, TX, is the applicant of record for K252219.

How long did the K252219 review take?

FDA received the submission on Jul 15, 2025 and issued its decision on Jan 14, 2026, 183 days later.

← All decisions in January 2026