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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name plate, fixation, bone
510(k) Number K202971
Device Name DRPx Locking Distal Radius Plate System
Applicant
Orthopaedic Implant Company
770 Smithridge Dr. #400
Reno,  NV  89502
Applicant Contact Douglas Fulton
Correspondent
Orthopaedic Implant Company
770 Smithridge Dr. #400
Reno,  NV  89502
Correspondent Contact Douglas Fulton
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HTN   HWC  
Date Received09/30/2020
Decision Date 05/06/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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