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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
510(k) Number K143113
Device Name Klassic BiPolar System
Applicant
Total Joint Orthopedics
1567 E. Stratford Ave.
Salt Lake City,  UT  84106
Applicant Contact Chris Weaber
Correspondent
Total Joint Orthopedics
1567 E. Stratford Ave.
Salt Lake City,  UT  84106
Correspondent Contact Chris Weaber
Regulation Number888.3390
Classification Product Code
KWY  
Date Received10/30/2014
Decision Date 01/28/2015
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
Recalls CDRH Recalls
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