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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name orthosis, spinal pedicle fixation, for degenerative disc disease
510(k) Number K122229
Device Name VICEROY SPINAL SYSTEM
Original Applicant
TORREY SPINE
4628 northpark drive
colorado springs,  CO  80918
Original Contact meredith may
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
MNH   MNI  
Date Received07/26/2012
Decision Date 11/20/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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