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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, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(k) Number K180929
Device Name Klassic HD® Hip System
Applicant
Total Joint Orthopedics, Inc.
1567 E. Stratford Ave.
Salt Lake City,  UT  84106
Applicant Contact Chris Weaber
Correspondent
Total Joint Orthopedics, Inc.
1567 E. Stratford Ave.
Salt Lake City,  UT  84106
Correspondent Contact Chris Weaber
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
LPH   LWJ   MBL   OQG  
Date Received04/09/2018
Decision Date 05/09/2018
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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