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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
510(k) Number K073143
Device Name MODIFIED VERTIFLEX SPINAL SCREW SYSTEM
Applicant
Vertiflex, Inc.
1351 Calle Avanzado
San Clamente,  CA  92673
Applicant Contact STEVE REITZLER
Correspondent
Vertiflex, Inc.
1351 Calle Avanzado
San Clamente,  CA  92673
Correspondent Contact STEVE REITZLER
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Codes
MNH   NKB  
Date Received11/07/2007
Decision Date 04/07/2008
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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