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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 / September 2025 / K252615

510(k) cleared

Ruthless Spine RJB

Ruthless, LLC Dba Ruthless Spine · Sep 17, 2025 · K252615

FDA cleared the Ruthless Spine RJB from Ruthless, LLC Dba Ruthless Spine on Sep 17, 2025 under K252615, a special 510(k). The device falls under product code QWL, Intraoperative Surgical Angle Measurement Tool, regulated at 21 CFR 888.4560 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Aug 19, 2025. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Ruthless, LLC Dba Ruthless Spine in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252615?

K252615 is the FDA 510(k) for Ruthless Spine RJB, submitted by Ruthless, LLC Dba Ruthless Spine. FDA's decision date was Sep 17, 2025, under product code QWL (Intraoperative Surgical Angle Measurement Tool).

Who makes the Ruthless Spine RJB?

Ruthless, LLC Dba Ruthless Spine, based in Irwindale, CA, is the applicant of record for K252615.

How long did the K252615 review take?

FDA received the submission on Aug 19, 2025 and issued its decision on Sep 17, 2025, 29 days later.

← All decisions in September 2025