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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 / April 2026 / K260570

510(k) cleared

corra cervical plating system

Carlsmed, Inc. · Apr 22, 2026 · K260570

FDA cleared the corra cervical plating system from Carlsmed, Inc. on Apr 22, 2026 under K260570, 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 Feb 19, 2026. The decision came 62 days later, inside the 90 FDA-day goal for a 510(k).

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), K252894 (aprevo® cervical interbody system), K252611 (aprevo® cervical plating system).

Questions & Answers

What did FDA clear under K260570?

K260570 is the FDA 510(k) for corra cervical plating system, submitted by Carlsmed, Inc.. FDA's decision date was Apr 22, 2026, under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body).

Who makes the corra cervical plating system?

Carlsmed, Inc., based in Carlsbad, CA, is the applicant of record for K260570.

How long did the K260570 review take?

FDA received the submission on Feb 19, 2026 and issued its decision on Apr 22, 2026, 62 days later.

← All decisions in April 2026