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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 K020170
Device Name KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UP
Applicant
ENCORE ORTHOPEDICS, INC.
9800 METRIC BLVD.
AUSTIN,  TX  78758
Applicant Contact JOANNA DROEGE
Correspondent
ENCORE ORTHOPEDICS, INC.
9800 METRIC BLVD.
AUSTIN,  TX  78758
Correspondent Contact JOANNA DROEGE
Regulation Number888.3358
Classification Product Code
LPH  
Date Received01/17/2002
Decision Date 02/11/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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