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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K051665
Device Name SYNTHES VECTRA-T SYSTEM
Applicant
SYNTHES SPINE
1380 ENTERPRISE DR.
WEST CHESTER,  PA  19380
Applicant Contact SUSAN LEWANDOWSKI
Correspondent
SYNTHES SPINE
1380 ENTERPRISE DR.
WEST CHESTER,  PA  19380
Correspondent Contact SUSAN LEWANDOWSKI
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received06/22/2005
Decision Date 09/09/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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