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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 K200196
Device Name Taperloc® Complete Hip Stems
Applicant
Biomet Orthopedics
56 E. Bell Dr.,
P.O. Box 587
Warsaw,  IN  46581
Applicant Contact Genoa Atwood
Correspondent
Biomet Orthopedics
56 E. Bell Dr.,
P.O. Box 587
Warsaw,  IN  46581
Correspondent Contact Genoa Atwood
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
JDI   KWL   KWY   KWZ   LPH  
MAY   MEH  
Date Received01/27/2020
Decision Date 12/08/2020
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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