WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

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 / June 2026 / K261651

510(k) cleared

Precice Max System and Precice Ankle Salvage System

NuVasive Specialized Orthopedics · Jun 18, 2026 · K261651

FDA cleared the Precice Max System and Precice Ankle Salvage System from NuVasive Specialized Orthopedics on Jun 18, 2026 under K261651, a special 510(k). The device falls under product code HSB, Rod, Fixation, Intramedullary And Accessories, regulated at 21 CFR 888.3020 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on May 19, 2026. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for NuVasive Specialized Orthopedics in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261651?

K261651 is the FDA 510(k) for Precice Max System and Precice Ankle Salvage System, submitted by NuVasive Specialized Orthopedics. FDA's decision date was Jun 18, 2026, under product code HSB (Rod, Fixation, Intramedullary And Accessories).

Who makes the Precice Max System and Precice Ankle Salvage System?

NuVasive Specialized Orthopedics, based in Audubon, PA, is the applicant of record for K261651.

How long did the K261651 review take?

FDA received the submission on May 19, 2026 and issued its decision on Jun 18, 2026, 30 days later.

← All decisions in June 2026