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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 K240113
Device Name CORIOGRAPH Knee Pre-Op Plan
Applicant
Smith & Nephew, Inc.
1450 Brooks Rd.
Memphis,  TN  38116
Applicant Contact Wilcox Miriam
Correspondent
Smith & Nephew, Inc.
1450 Brooks Rd.
Memphis,  TN  38116
Correspondent Contact Wilcox Miriam
Regulation Number888.3030
Classification Product Code
PBF  
Subsequent Product Codes
HSX   JWH   MBH   OOG  
Date Received01/16/2024
Decision Date 03/18/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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