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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 / K252461

510(k) cleared

Swedge Pedicle Screw Fixation System Bezier Rod

Spinal Resources, Inc. · Jan 13, 2026 · K252461

FDA cleared the Swedge Pedicle Screw Fixation System Bezier Rod from Spinal Resources, Inc. on Jan 13, 2026 under K252461, 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 Aug 5, 2025. The decision came 161 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 Spinal Resources, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252461?

K252461 is the FDA 510(k) for Swedge Pedicle Screw Fixation System Bezier Rod, submitted by Spinal Resources, Inc.. FDA's decision date was Jan 13, 2026, under product code NKB (Thoracolumbosacral Pedicle Screw System).

Who makes the Swedge Pedicle Screw Fixation System Bezier Rod?

Spinal Resources, Inc., based in Fort Lauderdale, FL, is the applicant of record for K252461.

How long did the K252461 review take?

FDA received the submission on Aug 5, 2025 and issued its decision on Jan 13, 2026, 161 days later.

← All decisions in January 2026