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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
510(k) Number K120292
Device Name CAPLOX II PEDICLE SCREW SYSTEM
Applicant
CAPTIVA SPINE, INC
13540 GUILD AVE
APPLE VALLEY,  MN  55124
Applicant Contact RICH JANSEN
Correspondent
CAPTIVA SPINE, INC
13540 GUILD AVE
APPLE VALLEY,  MN  55124
Correspondent Contact RICH JANSEN
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Code
MNH  
Date Received01/31/2012
Decision Date 04/13/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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