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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Fixation, Proximal Femoral, Implant
510(k) Number K230764
Device Name OsteoCentric Integrated Hip Fastener System
Applicant
OsteoCentric Technologies
75 W. 300 N.
Suite 150
Logan,  UT  84321
Applicant Contact Todd Evans
Correspondent
OsteoCentric Technologies
75 W. 300 N.
Suite 150
Logan,  UT  84321
Correspondent Contact Todd Evans
Regulation Number888.3030
Classification Product Code
JDO  
Subsequent Product Code
KTT  
Date Received03/20/2023
Decision Date 04/18/2023
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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