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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 / K251302

510(k) cleared

OptiMesh Multiplanar Expandable Interbody Fusion System

Spineology, Inc. · Dec 15, 2025 · K251302

FDA cleared the OptiMesh Multiplanar Expandable Interbody Fusion System from Spineology, Inc. on Dec 15, 2025 under K251302, a traditional 510(k). The device falls under product code OQB, Intervertebral Body Graft Containment Device, regulated at 21 CFR 888.3085 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Apr 28, 2025. The decision came 231 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Spineology, Inc. has one other decision in the tracker over the last 12 months: K251943 (Spineology Navigation Instruments).

Questions & Answers

What did FDA clear under K251302?

K251302 is the FDA 510(k) for OptiMesh Multiplanar Expandable Interbody Fusion System, submitted by Spineology, Inc.. FDA's decision date was Dec 15, 2025, under product code OQB (Intervertebral Body Graft Containment Device).

Who makes the OptiMesh Multiplanar Expandable Interbody Fusion System?

Spineology, Inc., based in Saint Paul, MN, is the applicant of record for K251302.

How long did the K251302 review take?

FDA received the submission on Apr 28, 2025 and issued its decision on Dec 15, 2025, 231 days later.

← All decisions in December 2025

Sources