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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 K073437
Device Name THOR ANTERIOR PLATING SYSTEM
Applicant
STRYKER SPINE
2 PEARL COURT
ALLENDALE,  NJ  07401
Applicant Contact CURTIS TRUESDALE
Correspondent
STRYKER SPINE
2 PEARL COURT
ALLENDALE,  NJ  07401
Correspondent Contact CURTIS TRUESDALE
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received12/06/2007
Decision Date 02/13/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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