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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K042437
Device Name DORSAL INTRAMEDULLARY PLATE
Applicant
Deo Volente Orthopaedics, LLC
P.O. Box 83
Warsaw,  IN  46581
Applicant Contact DINA L WEISSMAN, J.D.
Correspondent
Deo Volente Orthopaedics, LLC
P.O. Box 83
Warsaw,  IN  46581
Correspondent Contact DINA L WEISSMAN, J.D.
Regulation Number888.3030
Classification Product Code
HRS  
Date Received09/08/2004
Decision Date 10/08/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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