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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 K171082
Device Name Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spinal Fixation System, Firebird NXG Spinal Fixation System
Applicant
Orthofix, Inc.
3451 Plano Pkwy.
Lweisville,  TX  75056
Applicant Contact Jacki Koch
Correspondent
Orthofix, Inc.
3451 Plano Pkwy.
Lweisville,  TX  75056
Correspondent Contact Jacki Koch
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ  
Date Received04/11/2017
Decision Date 05/05/2017
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
Recalls CDRH Recalls
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