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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, for degenerative disc disease
510(k) Number K042953
Device Name MODIFICATION TO PROTEX STABILIZATION SYSTEM
Original Applicant
GLOBUS MEDICAL, INC.
303 schell lane
phoenixville,  PA  19460
Original Contact kelly j baker
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI  
Date Received10/26/2004
Decision Date 11/22/2004
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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