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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 / July 2026 / K260556

510(k) cleared

Veritas Shoulder System

Restor3D · Jul 1, 2026 · K260556

FDA cleared the Veritas Shoulder System from Restor3D on Jul 1, 2026 under K260556, a traditional 510(k). The device falls under product code PHX, Shoulder Prosthesis, Reverse Configuration, regulated at 21 CFR 888.3660 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Feb 19, 2026. The decision came 132 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Restor3D has 2 other decisions in the tracker over the last 12 months: K253992 (Veritas Reverse Total Shoulder System), K252067 (Velora Acetabular System).

Questions & Answers

What did FDA clear under K260556?

K260556 is the FDA 510(k) for Veritas Shoulder System, submitted by Restor3D. FDA's decision date was Jul 1, 2026, under product code PHX (Shoulder Prosthesis, Reverse Configuration).

Who makes the Veritas Shoulder System?

Restor3D, based in Durham, NC, is the applicant of record for K260556.

How long did the K260556 review take?

FDA received the submission on Feb 19, 2026 and issued its decision on Jul 1, 2026, 132 days later.

← All decisions in July 2026

Sources