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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 K053293
Device Name ENCOMPASS 10*17 AND 12*17 EXTENDED PRESS-FIT HIP STEMS
Applicant
ORTHO DEVELOPMENT CORP.
12187 SOUTH BUSINESS PARK DR.
DRAPER,  UT  84020
Applicant Contact WILLIAM J GRIFFIN
Correspondent
ORTHO DEVELOPMENT CORP.
12187 SOUTH BUSINESS PARK DR.
DRAPER,  UT  84020
Correspondent Contact WILLIAM J GRIFFIN
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Code
MBL  
Date Received11/25/2005
Decision Date 02/16/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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