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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 K130176
Device Name FIREBIRD SPINAL FIXATION SYSTEM
Applicant
Orthofix
3451 Plano Pkwy.
Lewisville,  TX  75056
Applicant Contact JACKI GEREN
Correspondent
Orthofix
3451 Plano Pkwy.
Lewisville,  TX  75056
Correspondent Contact JACKI GEREN
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
MNH   MNI  
Date Received01/25/2013
Decision Date 03/28/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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