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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 / March 2026 / K254045

510(k) cleared

CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System

CarboFix Orthopedics , Ltd. · Mar 16, 2026 · K254045

FDA cleared the CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System from CarboFix Orthopedics , Ltd. on Mar 16, 2026 under K254045, a traditional 510(k). The device falls under product code NKG, Posterior Cervical Screw System, regulated at 21 CFR 888.3075 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Dec 17, 2025. The decision came 89 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for CarboFix Orthopedics , Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254045?

K254045 is the FDA 510(k) for CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System, submitted by CarboFix Orthopedics , Ltd.. FDA's decision date was Mar 16, 2026, under product code NKG (Posterior Cervical Screw System).

Who makes the CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System?

CarboFix Orthopedics , Ltd., based in Herzeliya, is the applicant of record for K254045.

How long did the K254045 review take?

FDA received the submission on Dec 17, 2025 and issued its decision on Mar 16, 2026, 89 days later.

← All decisions in March 2026