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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Bone Graft, Lumbar
510(k) Number K252113
Device Name PRADO™ Lumbar Interbody Fusion System
Applicant
Bethesda Medical Devices
2985 Nationwide Pkwy.
Brunswick,  OH  44212
Applicant Contact Amanda Shade
Correspondent
Bethesda Medical Devices
2985 Nationwide Pkwy.
Brunswick,  OH  44212
Correspondent Contact Amanda Shade
Regulation Number888.3080
Classification Product Code
MAX  
Date Received07/07/2025
Decision Date 08/05/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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