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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 K033352
Device Name VERTEBRON PSS PEDICLE SCREW SYSTEM
Applicant
Vertebron, Inc.
136 Albert Ave.
Stratford,  CT  06614
Applicant Contact BRUCE KHALILI
Correspondent
Vertebron, Inc.
136 Albert Ave.
Stratford,  CT  06614
Correspondent Contact BRUCE KHALILI
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   KWQ   MNH  
Date Received10/20/2003
Decision Date 02/25/2004
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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