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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, Spinal Interlaminal
510(k) Number K990986
Device Name CONTOUR SPINAL SYSTEM
Applicant
Ortho Development Corp.
106 W. 12200 S.
Draper,  UT  84020
Applicant Contact CAROL FREASIER
Correspondent
Ortho Development Corp.
106 W. 12200 S.
Draper,  UT  84020
Correspondent Contact CAROL FREASIER
Regulation Number888.3050
Classification Product Code
KWP  
Subsequent Product Code
MNH  
Date Received03/24/1999
Decision Date 10/14/1999
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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