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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spondylolisthesis Spinal Fixation
510(k) Number K043152
Device Name VERTEBRON PSS PEDICLE SCREW SYSTEM
Applicant
Vertebron, Inc.
400 Long Beach Blvd.
Stratford,  CT  06615
Applicant Contact LUIS NESPRIDO
Correspondent
Vertebron, Inc.
400 Long Beach Blvd.
Stratford,  CT  06615
Correspondent Contact LUIS NESPRIDO
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Codes
KWP   KWQ   MNI  
Date Received11/15/2004
Decision Date 02/01/2005
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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