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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K100146
Device Name EVOLVE EPS ORTHOLOC
Applicant
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 AIRLINE RD.
ARLINGTON,  TN  38002
Applicant Contact KELSEY LEE
Correspondent
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 AIRLINE RD.
ARLINGTON,  TN  38002
Correspondent Contact KELSEY LEE
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received01/19/2010
Decision Date 02/02/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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