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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 K112794
Device Name EOS SMALL BONE FIXATION SYSTEM
Applicant
TRIMED, INC.
27533 AVENUE HOPKINS
SANTA CLARITA,  CA  91355
Applicant Contact DOUG STEINBERGER
Correspondent
TRIMED, INC.
27533 AVENUE HOPKINS
SANTA CLARITA,  CA  91355
Correspondent Contact DOUG STEINBERGER
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HTY   HWC   JDR  
Date Received09/26/2011
Decision Date 05/10/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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