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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 K042859
Device Name KOBRA GPS FIXATION SYSTEM
Applicant
Medtronic Vertelink, Inc.
27001 La Paz, Suite 312
Mission Viejo,  CA  92691
Applicant Contact ALBERT REGO
Correspondent
Medtronic Vertelink, Inc.
27001 La Paz, Suite 312
Mission Viejo,  CA  92691
Correspondent Contact ALBERT REGO
Regulation Number888.3060
Classification Product Code
KWQ  
Subsequent Product Codes
MNH   MNI  
Date Received10/15/2004
Decision Date 11/24/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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