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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 / April 2026 / K260660

510(k) cleared

SABER-C System

Elevation Spine · Apr 27, 2026 · K260660

FDA cleared the SABER-C System from Elevation Spine on Apr 27, 2026 under K260660, a traditional 510(k). The device falls under product code OVE, Intervertebral Fusion Device With Integrated Fixation, Cervical, regulated at 21 CFR 888.3080 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Mar 2, 2026. The decision came 56 days later, inside the 90 FDA-day goal for a 510(k).

Elevation Spine has one other decision in the tracker over the last 12 months: K261408 (SABER-XA System).

Questions & Answers

What did FDA clear under K260660?

K260660 is the FDA 510(k) for SABER-C System, submitted by Elevation Spine. FDA's decision date was Apr 27, 2026, under product code OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical).

Who makes the SABER-C System?

Elevation Spine, based in Monteray, CA, is the applicant of record for K260660.

How long did the K260660 review take?

FDA received the submission on Mar 2, 2026 and issued its decision on Apr 27, 2026, 56 days later.

← All decisions in April 2026

Sources