FDA 510(k)

Palisades™ Buttress Plate System

K-Nummer: K261309 · 2026-07-16

AntragstellerBethesda Medical Devices, LLC

Entscheidungsdatum2026-07-16

ProduktcodeKWQ

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

Palisades™ Buttress Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Bethesda Medical Devices, LLC. It received FDA 510(k) clearance on 2026-07-16 under 510(k) number K261309. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Palisades™ Buttress Plate System?

Palisades™ Buttress Plate System is a medical device that received FDA 510(k) clearance on 2026-07-16. The listed applicant is Bethesda Medical Devices, LLC. The 510(k) number is K261309.

When did Palisades™ Buttress Plate System receive FDA 510(k) clearance?

Palisades™ Buttress Plate System received FDA 510(k) clearance on 2026-07-16, under 510(k) number K261309.

Who is the listed applicant for Palisades™ Buttress Plate System?

The FDA 510(k) record lists Bethesda Medical Devices, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Palisades™ Buttress Plate System?

The FDA product code for Palisades™ Buttress Plate System is KWQ.

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Verwandte Geräte (Code: KWQ)

K262149corra® cervical plating systemCarlsmed, Inc.K252776ARIES Vorderes Halsplatten-SystemZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.K260570corra™ cervical plating systemCarlsmed, Inc.K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLC K260015ANTERIS Thorakolombale Platten-SystemSpineCraft

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