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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K093676
Device Name OMNITECH LARGE, TRIMED COMPRESSION SCREW
Applicant
TriMed, Inc.
25864 Tournament Rd. Suite A
Valencia,  CA  91355
Applicant Contact KELLI ANDERSON
Correspondent
TriMed, Inc.
25864 Tournament Rd. Suite A
Valencia,  CA  91355
Correspondent Contact KELLI ANDERSON
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
HTY  
Date Received11/27/2009
Decision Date 03/17/2010
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
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