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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name hip prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented
510(k) Number K140130
Device Name X-ALT HIGHLY CROSS LINKED ACETABULAR LINERS WITH VITAMIN E, NEUTRAL, 10 DEGREE HOODED, 20 DEGREE HOODED
Applicant
ENCORE MEDICAL, L.P.
9800 METRIC BLVD.
AUSTIN,  TX  78758
Applicant Contact TEFFANY HUTTO
Correspondent
ENCORE MEDICAL, L.P.
9800 METRIC BLVD.
AUSTIN,  TX  78758
Correspondent Contact TEFFANY HUTTO
Regulation Number888.3358
Classification Product Code
OQG  
Subsequent Product Code
LPH  
Date Received01/17/2014
Decision Date 11/06/2014
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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