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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 K000521
Device Name KEYSTONE HIP
Applicant
ENCORE ORTHOPEDICS, INC.
9800 METRIC BLVD.
AUSTIN,  TX  78758
Applicant Contact DEBBIE DE LOS SANTOS
Correspondent
ENCORE ORTHOPEDICS, INC.
9800 METRIC BLVD.
AUSTIN,  TX  78758
Correspondent Contact DEBBIE DE LOS SANTOS
Regulation Number888.3358
Classification Product Code
LPH  
Date Received02/16/2000
Decision Date 05/10/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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