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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 K874377
Device Name ANATOMIC ADJUSTABLE AXIAL FIXATOR ASSEMBLY
Applicant
Harrington Arthritis Research Center
1800 E. Van Buren
Phoenix,  AZ  85006
Applicant Contact JAMES B KOENEMAN
Correspondent
Harrington Arthritis Research Center
1800 E. Van Buren
Phoenix,  AZ  85006
Correspondent Contact JAMES B KOENEMAN
Regulation Number888.3030
Classification Product Code
LXT  
Date Received10/26/1987
Decision Date 05/20/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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