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FDA 510(k)

Palisades™ Buttress Plate System

K-Number: K261309 · 2026-07-16

ApplicantBethesda Medical Devices, LLC
Decision Date2026-07-16
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Bethesda Medical Devices, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252113PRADO™ Lumbar Interbody Fusion System

Related Devices (Code: KWQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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