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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 / August 2026 / K261408

510(k) cleared

SABER-XA System

Elevation Spine · Aug 3, 2026 · K261408

FDA cleared the SABER-XA System from Elevation Spine on Aug 3, 2026 under K261408, a traditional 510(k). The device falls under product code OVD, Intervertebral Fusion Device With Integrated Fixation, Lumbar, regulated at 21 CFR 888.3080 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Apr 30, 2026. The decision came 95 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Elevation Spine has one other decision in the tracker over the last 12 months: K260660 (SABER-C System).

Questions & Answers

What did FDA clear under K261408?

K261408 is the FDA 510(k) for SABER-XA System, submitted by Elevation Spine. FDA's decision date was Aug 3, 2026, under product code OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar).

Who makes the SABER-XA System?

Elevation Spine, based in Monteray, CA, is the applicant of record for K261408.

How long did the K261408 review take?

FDA received the submission on Apr 30, 2026 and issued its decision on Aug 3, 2026, 95 days later.

← All decisions in August 2026

Sources