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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 / K253943

510(k) cleared

Tiger 2 System

Zavation Medical Products, LLC · Jul 24, 2026 · K253943

FDA cleared the Tiger 2 System from Zavation Medical Products, LLC on Jul 24, 2026 under K253943, a traditional 510(k). The device falls under product code NKB, Thoracolumbosacral Pedicle Screw System, regulated at 21 CFR 888.3070 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Dec 10, 2025. The decision came 226 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Zavation Medical Products, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253943?

K253943 is the FDA 510(k) for Tiger 2 System, submitted by Zavation Medical Products, LLC. FDA's decision date was Jul 24, 2026, under product code NKB (Thoracolumbosacral Pedicle Screw System).

Who makes the Tiger 2 System?

Zavation Medical Products, LLC, based in Flowood, MS, is the applicant of record for K253943.

How long did the K253943 review take?

FDA received the submission on Dec 10, 2025 and issued its decision on Jul 24, 2026, 226 days later.

← All decisions in July 2026