WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / June 2026 / K260286

510(k) cleared

Dynamo Spinal Cement; Salvo® Spine System

Spine Wave, Inc. · Jun 15, 2026 · K260286

FDA cleared the Dynamo Spinal Cement; Salvo® Spine System from Spine Wave, Inc. on Jun 15, 2026 under K260286, a traditional 510(k). The device falls under product code PML, Bone Cement, Posterior Screw Augmentation, regulated at 21 CFR 888.3027 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jan 29, 2026. The decision came 137 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Spine Wave, Inc. has one other decision in the tracker over the last 12 months: K261159 (Exceed® Biplanar Expandable Interbody System).

Questions & Answers

What did FDA clear under K260286?

K260286 is the FDA 510(k) for Dynamo Spinal Cement; Salvo® Spine System, submitted by Spine Wave, Inc.. FDA's decision date was Jun 15, 2026, under product code PML (Bone Cement, Posterior Screw Augmentation).

Who makes the Dynamo Spinal Cement; Salvo® Spine System?

Spine Wave, Inc., based in Shelton, CT, is the applicant of record for K260286.

How long did the K260286 review take?

FDA received the submission on Jan 29, 2026 and issued its decision on Jun 15, 2026, 137 days later.

← All decisions in June 2026

Sources