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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 / July 2026 / K252822

510(k) cleared

Atlas Spine HiRISE Expandable Cervical-p Corpectomy Implant

Atlas Spine, Inc. · Jul 15, 2026 · K252822

FDA cleared the Atlas Spine HiRISE Expandable Cervical-p Corpectomy Implant from Atlas Spine, Inc. on Jul 15, 2026 under K252822, 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 Sep 4, 2025. The decision came 314 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Atlas Spine, Inc. has one other decision in the tracker over the last 12 months: K252560 (Atlas Spine HiRISE Expandable Cervical Corpectomy System).

Questions & Answers

What did FDA clear under K252822?

K252822 is the FDA 510(k) for Atlas Spine HiRISE Expandable Cervical-p Corpectomy Implant, submitted by Atlas Spine, Inc.. FDA's decision date was Jul 15, 2026, under product code PLR (Spinal Vertebral Body Replacement Device - Cervical).

Who makes the Atlas Spine HiRISE Expandable Cervical-p Corpectomy Implant?

Atlas Spine, Inc., based in Jupiter, FL, is the applicant of record for K252822.

How long did the K252822 review take?

FDA received the submission on Sep 4, 2025 and issued its decision on Jul 15, 2026, 314 days later.

← All decisions in July 2026

Sources