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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K223761
Device Name OIC Intramedullary Screw 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 Number888.3040
Classification Product Code
HWC  
Date Received12/15/2022
Decision Date 02/13/2023
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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