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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 / K253266

510(k) cleared

Titanium Interbody System

Spine Innovation, LLC · Jan 8, 2026 · K253266

FDA cleared the Titanium Interbody System from Spine Innovation, LLC on Jan 8, 2026 under K253266, a special 510(k). The device falls under product code MAX, Intervertebral Fusion Device With Bone Graft, Lumbar, regulated at 21 CFR 888.3080 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Sep 29, 2025. The decision came 101 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 Spine Innovation, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253266?

K253266 is the FDA 510(k) for Titanium Interbody System, submitted by Spine Innovation, LLC. FDA's decision date was Jan 8, 2026, under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar).

Who makes the Titanium Interbody System?

Spine Innovation, LLC, based in Coronado, CA, is the applicant of record for K253266.

How long did the K253266 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on Jan 8, 2026, 101 days later.

← All decisions in January 2026