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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 K121024
Device Name LINEAR POROUS COATED HIP STEM, SIZE 5; REVELATION HIP STEM, SIZE 8; FOUNDATION POROUS PRESS FIT STEM, SIZE 8;
Applicant
ENCORE MEDICAL, L.P.
9800 metric blvd.
austin,  TX  78758
Applicant Contact william garzon
Correspondent
ENCORE MEDICAL, L.P.
9800 metric blvd.
austin,  TX  78758
Correspondent Contact william garzon
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
JDG   JDI   LZO  
Date Received04/04/2012
Decision Date 06/19/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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