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THE TAPE

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 / November 2025 / K252560

510(k) cleared

Atlas Spine HiRISE Expandable Cervical Corpectomy System

Atlas Spine, Inc. · Nov 10, 2025 · K252560

FDA cleared the Atlas Spine HiRISE Expandable Cervical Corpectomy System from Atlas Spine, Inc. on Nov 10, 2025 under K252560, a traditional 510(k). The device falls under product code PLR, Spinal Vertebral Body Replacement Device - Cervical, regulated at 21 CFR 888.3060 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Aug 13, 2025. The decision came 89 days later, inside the 90 FDA-day goal for a 510(k).

Atlas Spine, Inc. has one other decision in the tracker over the last 12 months: K252822 (Atlas Spine HiRISE Expandable Cervical-p Corpectomy Implant).

Questions & Answers

What did FDA clear under K252560?

K252560 is the FDA 510(k) for Atlas Spine HiRISE Expandable Cervical Corpectomy System, submitted by Atlas Spine, Inc.. FDA's decision date was Nov 10, 2025, under product code PLR (Spinal Vertebral Body Replacement Device - Cervical).

Who makes the Atlas Spine HiRISE Expandable Cervical Corpectomy System?

Atlas Spine, Inc., based in Jupiter, FL, is the applicant of record for K252560.

How long did the K252560 review take?

FDA received the submission on Aug 13, 2025 and issued its decision on Nov 10, 2025, 89 days later.

← All decisions in November 2025

Sources