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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopaedic Surgical Planning And Instrument Guides
510(k) Number K252064
Device Name MedCAD® AccuStride™ System
Applicant
Medcad
501 S 2nd Ave.
Suite A-1000
Dallas,  TX  75226
Applicant Contact Brian Buss
Correspondent
Secure BioMed Evaluations
7828 Hickory Flat Hwy.
Woodstock,  GA  30188
Correspondent Contact Justin Gracyalny
Regulation Number888.3030
Classification Product Code
PBF  
Date Received07/01/2025
Decision Date 03/27/2026
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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