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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
510(k) Number K890989
Device Name DR. HERZBERG DISPOSABLE EXTERNAL FIXATOR
Applicant
Origin Medsystems, Inc.
1900 S. Norfolk St.,
Suite 312
San Mateo,  CA  94403
Applicant Contact MOLL, M.D.
Correspondent
Origin Medsystems, Inc.
1900 S. Norfolk St.,
Suite 312
San Mateo,  CA  94403
Correspondent Contact MOLL, M.D.
Regulation Number888.3030
Classification Product Code
KTT  
Date Received02/28/1989
Decision Date 04/05/1990
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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