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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 K043263
Device Name TRIMED OSTEOTOMY PLATE
Applicant
TriMed, Inc.
28337 Maitland Ln.
Saugus,  CA  91350
Applicant Contact KELLI ANDERSON
Correspondent
TriMed, Inc.
28337 Maitland Ln.
Saugus,  CA  91350
Correspondent Contact KELLI ANDERSON
Regulation Number888.3030
Classification Product Code
HRS  
Date Received11/24/2004
Decision Date 01/14/2005
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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