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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
510(k) Number K073135
Device Name SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONS
Applicant
Synthes (Usa)
1302 Wrights Ln. E.
West Chester,  PA  19380
Applicant Contact JILL SHERMAN
Correspondent
Synthes (Usa)
1302 Wrights Ln. E.
West Chester,  PA  19380
Correspondent Contact JILL SHERMAN
Regulation Number888.3030
Classification Product Code
LXT  
Date Received11/07/2007
Decision Date 01/29/2008
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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