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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 K102785
Device Name TRIMED RADIOCARPAL FUSION SYSTEM
Applicant
TriMed, Inc.
28337 Maitland Ln.
Saugus,  CA  91350
Applicant Contact DAVID ANDERSON
Correspondent
TriMed, Inc.
28337 Maitland Ln.
Saugus,  CA  91350
Correspondent Contact DAVID ANDERSON
Regulation Number888.3030
Classification Product Code
HRS  
Date Received09/27/2010
Decision Date 08/19/2011
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
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