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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
Applicant
GLOBUS MEDICAL, INC.
303 schell lane
phoenixville,  PA  19460
Applicant Contact kelly j baker
Correspondent
GLOBUS MEDICAL, INC.
303 schell lane
phoenixville,  PA  19460
Correspodent 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 (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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