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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cerclage, Fixation
510(k) Number K951844
Device Name BIOMECHANIC LOW-PROFILE CABLE SYSTEM
Applicant
Biomechanic, Inc.
12634 Olive Blvd.
Creve Coeur,  MO  63141
Applicant Contact MICHAEL WALL
Correspondent
Biomechanic, Inc.
12634 Olive Blvd.
Creve Coeur,  MO  63141
Correspondent Contact MICHAEL WALL
Regulation Number888.3010
Classification Product Code
JDQ  
Date Received04/20/1995
Decision Date 07/13/1995
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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