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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 -4370
Applicant Contact SCOTT HUNTLEY
Correspondent
APPLIED OSTEO SYSTEMS, INC.
1243 ALPINE RD.
SUITE 221
WALNUT CREEK,  CA  94596 -4370
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
Recalls CDRH Recalls
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