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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/Polymer, Porous Uncemented
510(k) Number K251270
Device Name Taperloc® Complete Hip Stem
Applicant
Biomet, Inc.
56 E. Bell Dr.,
P.O. Box 587
Warsaw,  IN  46581
Applicant Contact Dora Hu
Correspondent
Biomet, Inc.
56 E. Bell Dr.,
P.O. Box 587
Warsaw,  IN  46581
Correspondent Contact Neha Sreenath
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
KWY   KWZ   MAY   MEH   OQG  
Date Received04/24/2025
Decision Date 05/19/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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