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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 / June 2026 / K261207

510(k) cleared

Exalta Proximal Tibia Plating System

Tyber Medical, LLC · Jun 12, 2026 · K261207

FDA cleared the Exalta Proximal Tibia Plating System from Tyber Medical, LLC on Jun 12, 2026 under K261207, a traditional 510(k). The device falls under product code HRS, Plate, Fixation, Bone, regulated at 21 CFR 888.3030 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Apr 13, 2026. The decision came 60 days later, inside the 90 FDA-day goal for a 510(k).

Tyber Medical, LLC has 5 other decisions in the tracker over the last 12 months: K260810 (Anteralign LS coverplate), K261060 (Navigated LLIF Impactable Tracker), K253042 (Tyber Medical Trauma Screw), K252901 (Tyber Medical Trauma Screw).

Questions & Answers

What did FDA clear under K261207?

K261207 is the FDA 510(k) for Exalta Proximal Tibia Plating System, submitted by Tyber Medical, LLC. FDA's decision date was Jun 12, 2026, under product code HRS (Plate, Fixation, Bone).

Who makes the Exalta Proximal Tibia Plating System?

Tyber Medical, LLC, based in Bethlehem, PA, is the applicant of record for K261207.

How long did the K261207 review take?

FDA received the submission on Apr 13, 2026 and issued its decision on Jun 12, 2026, 60 days later.

← All decisions in June 2026

Sources