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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, External Fixator (With Metallic Invasive Components)
510(k) Number K101375
Device Name TRIMED X-FIX
Applicant
TriMed, Inc.
28337 Maitland Lane
Saugus,  CA  91350
Applicant Contact KELLI ANDERSON
Correspondent
TriMed, Inc.
28337 Maitland Lane
Saugus,  CA  91350
Correspondent Contact KELLI ANDERSON
Regulation Number888.3040
Classification Product Code
NDK  
Date Received05/17/2010
Decision Date 09/15/2010
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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