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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K991151
Device Name VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW, ORTHEX CANNULATED BONE SCREW
Applicant
Vilex, Inc.
1801 Rt. 51, Bldg. 10
Jefferson Hills,  PA  15025 -0724
Applicant Contact ABRAHIM LAVI
Correspondent
Vilex, Inc.
1801 Rt. 51, Bldg. 10
Jefferson Hills,  PA  15025 -0724
Correspondent Contact ABRAHIM LAVI
Regulation Number888.3040
Classification Product Code
HWC  
Date Received04/06/1999
Decision Date 04/26/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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