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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Nail/Blade/Plate Combination, Single Component
510(k) Number K931682
Device Name CANNULATED MALLEOLAR SCREW
Applicant
Onyx Medical Corp.
152 Collins St.
Memphis,  TN  38112
Applicant Contact LARAINE B GILMORE
Correspondent
Onyx Medical Corp.
152 Collins St.
Memphis,  TN  38112
Correspondent Contact LARAINE B GILMORE
Regulation Number888.3030
Classification Product Code
KWK  
Date Received04/05/1993
Decision Date 04/05/1994
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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