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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 / July 2026 / K254130

510(k) cleared

C.A. Medical Interbody Fusion System

C.A. Medical, LLC · Jul 8, 2026 · K254130

FDA cleared the C.A. Medical Interbody Fusion System from C.A. Medical, LLC on Jul 8, 2026 under K254130, a special 510(k). The device falls under product code ODP, Intervertebral Fusion Device With Bone Graft, Cervical, regulated at 21 CFR 888.3080 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Dec 22, 2025. The decision came 198 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

C.A. Medical, LLC has 8 other decisions in the tracker over the last 12 months: K253808 (AIR Recon DL), K253667 (Accoat Guide Wire), K253317 (Cytrans Elashield), K253802 (KHEIRON® Spinal Fixation System, including patient specific K-ROD).

Questions & Answers

What did FDA clear under K254130?

K254130 is the FDA 510(k) for C.A. Medical Interbody Fusion System, submitted by C.A. Medical, LLC. FDA's decision date was Jul 8, 2026, under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical).

Who makes the C.A. Medical Interbody Fusion System?

C.A. Medical, LLC, based in Southlake, TX, is the applicant of record for K254130.

How long did the K254130 review take?

FDA received the submission on Dec 22, 2025 and issued its decision on Jul 8, 2026, 198 days later.

← All decisions in July 2026