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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K142146
Device Name IBIS PEDICLE SCREW SYSTEM
Applicant
Ortho Development Corp.
12187 S. Business Park Dr.
Draper,  UT  84020
Applicant Contact MIKE ENSIGN
Correspondent
Ortho Development Corp.
12187 S. Business Park Dr.
Draper,  UT  84020
Correspondent Contact MIKE ENSIGN
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
MNH   MNI  
Date Received08/05/2014
Decision Date 12/11/2014
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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