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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 / K252894

510(k) cleared

aprevo® cervical interbody system

Carlsmed, Inc. · Jan 6, 2026 · K252894

FDA cleared the aprevo® cervical interbody system from Carlsmed, Inc. on Jan 6, 2026 under K252894, a traditional 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 Sep 11, 2025. The decision came 117 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), K252611 (aprevo® cervical plating system).

Questions & Answers

What did FDA clear under K252894?

K252894 is the FDA 510(k) for aprevo® cervical interbody system, submitted by Carlsmed, Inc.. FDA's decision date was Jan 6, 2026, under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical).

Who makes the aprevo® cervical interbody system?

Carlsmed, Inc., based in Carlsbad, CA, is the applicant of record for K252894.

How long did the K252894 review take?

FDA received the submission on Sep 11, 2025 and issued its decision on Jan 6, 2026, 117 days later.

← All decisions in January 2026