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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name orthosis, spondylolisthesis spinal fixation
510(k) Number K131538
Device Name CAPLOX II PEDICLE SCREW SYSTEM/TOWERLOX PEDICLE SCREW SYSTEM
Applicant
CAPTIVA SPINE
13540 GUILD AVE
APPLE VALLY,  MN  55124
Applicant Contact RICH JANSEN
Correspondent
CAPTIVA SPINE
13540 GUILD AVE
APPLE VALLY,  MN  55124
Correspondent Contact RICH JANSEN
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Code
MNI  
Date Received05/29/2013
Decision Date 08/08/2013
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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