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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 K843449
Device Name AUTODYNAMIC COMPRESSION HIP SCREW-PLATE
Applicant
Mecron Medical Products, Inc.
P.O. Box 1139
Port Washington,  NY  11050
Applicant Contact EMMANUEL ANAPLIOTIS
Correspondent
Mecron Medical Products, Inc.
P.O. Box 1139
Port Washington,  NY  11050
Correspondent Contact EMMANUEL ANAPLIOTIS
Regulation Number888.3030
Classification Product Code
KTT  
Date Received09/05/1984
Decision Date 10/22/1984
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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