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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 K141291
Device Name VERTIFORM POSTERIOR FIXATION SYSTEM
Applicant
Next Orthosurgical
3270 Corporate Vw Suite A
Vista,  CA  92081
Applicant Contact HUAN TRAN
Correspondent
Next Orthosurgical
3270 Corporate Vw Suite A
Vista,  CA  92081
Correspondent Contact HUAN TRAN
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
MNH   MNI   OSH  
Date Received05/19/2014
Decision Date 08/26/2014
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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