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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 K941048
Device Name TRUE/LOK MONOLATERAL/BILATERAL FIXATOR
Applicant
Applied Osteo Systems, Inc.
1243 Alpine Rd.
Suite 221
Walnut Creek,  CA  94596
Applicant Contact SCOTT HUNTLEY
Correspondent
Applied Osteo Systems, Inc.
1243 Alpine Rd.
Suite 221
Walnut Creek,  CA  94596
Correspondent Contact SCOTT HUNTLEY
Regulation Number888.3030
Classification Product Code
LXT  
Date Received03/07/1994
Decision Date 10/03/1994
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
Recalls CDRH Recalls
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