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 / July 2026 / K261309

510(k) cleared

Palisades Buttress Plate System

Bethesda Medical Devices, LLC · Jul 16, 2026 · K261309

FDA cleared the Palisades Buttress Plate System from Bethesda Medical Devices, LLC on Jul 16, 2026 under K261309, a traditional 510(k). The device falls under product code KWQ, Appliance, Fixation, Spinal Intervertebral Body, regulated at 21 CFR 888.3060 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Apr 21, 2026. The decision came 86 days later, inside the 90 FDA-day goal for a 510(k).

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

Questions & Answers

What did FDA clear under K261309?

K261309 is the FDA 510(k) for Palisades Buttress Plate System, submitted by Bethesda Medical Devices, LLC. FDA's decision date was Jul 16, 2026, under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body).

Who makes the Palisades Buttress Plate System?

Bethesda Medical Devices, LLC, based in Brunswick, OH, is the applicant of record for K261309.

How long did the K261309 review take?

FDA received the submission on Apr 21, 2026 and issued its decision on Jul 16, 2026, 86 days later.

← All decisions in July 2026