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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 / K253093

510(k) cleared

Vital Spinal Fixation System

Highridge Medical, LLC · Dec 17, 2025 · K253093

FDA cleared the Vital Spinal Fixation System from Highridge Medical, LLC on Dec 17, 2025 under K253093, a traditional 510(k). The device falls under product code NKB, Thoracolumbosacral Pedicle Screw System, regulated at 21 CFR 888.3070 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Sep 23, 2025. The decision came 85 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Highridge Medical, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253093?

K253093 is the FDA 510(k) for Vital Spinal Fixation System, submitted by Highridge Medical, LLC. FDA's decision date was Dec 17, 2025, under product code NKB (Thoracolumbosacral Pedicle Screw System).

Who makes the Vital Spinal Fixation System?

Highridge Medical, LLC, based in Westminister, CO, is the applicant of record for K253093.

How long did the K253093 review take?

FDA received the submission on Sep 23, 2025 and issued its decision on Dec 17, 2025, 85 days later.

← All decisions in December 2025