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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 K110046
Device Name ATHENA PEDICLE SCREW SYSTEM
Applicant
Royal Oak Medical Devices
39533 Woodward Ave.
Bloomfield Hills,  MI  48304
Applicant Contact MATHEW KROLL
Correspondent
Royal Oak Medical Devices
39533 Woodward Ave.
Bloomfield Hills,  MI  48304
Correspondent Contact MATHEW KROLL
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
MNH   MNI  
Date Received01/06/2011
Decision Date 12/07/2011
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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