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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K261309
Device Name Palisades™ Buttress Plate System
Applicant
Bethesda Medical Devices, LLC
2985 Nationwide Pkwy.
Brunswick,  OH  44212
Applicant Contact Amanda Shade
Correspondent
Bethesda Medical Devices, LLC
2985 Nationwide Pkwy.
Brunswick,  OH  44212
Correspondent Contact Amanda Shade
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received04/21/2026
Decision Date 07/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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