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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 K103384
Device Name ESCALADE ACETABULAR CUP SYSTEM
Applicant
ORTHO DEVELOPMENT
12187 S. BUSINESS PARK DR.
DRAPER,  UT  84020
Applicant Contact TOM HAUETER
Correspondent
ORTHO DEVELOPMENT
12187 S. BUSINESS PARK DR.
DRAPER,  UT  84020
Correspondent Contact TOM HAUETER
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Code
LZO  
Date Received11/18/2010
Decision Date 03/16/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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