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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 / K252611

510(k) cleared

aprevo® cervical plating system

Carlsmed, Inc. · Dec 22, 2025 · K252611

FDA cleared the aprevo® cervical plating system from Carlsmed, Inc. on Dec 22, 2025 under K252611, a traditional 510(k). The device falls under product code KWQ, Appliance, Fixation, Spinal Intervertebral Body, regulated at 21 CFR 888.3060 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Aug 18, 2025. The decision came 126 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Carlsmed, Inc. has 3 other decisions in the tracker over the last 12 months: K260385 (aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra cervical plating system), K260570 (corra cervical plating system), K252894 (aprevo® cervical interbody system).

Questions & Answers

What did FDA clear under K252611?

K252611 is the FDA 510(k) for aprevo® cervical plating system, submitted by Carlsmed, Inc.. FDA's decision date was Dec 22, 2025, under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body).

Who makes the aprevo® cervical plating system?

Carlsmed, Inc., based in Carlsbad, CA, is the applicant of record for K252611.

How long did the K252611 review take?

FDA received the submission on Aug 18, 2025 and issued its decision on Dec 22, 2025, 126 days later.

← All decisions in December 2025