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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K051275
Device Name LAGUNA MONOAXIAL PEDICLE SCREW SYSTEM
Applicant
ALLEZ SPINE, LLC
2009 FREDA LANE
CARDIFF,  CA  92007
Applicant Contact HARTMUT LOCH
Correspondent
ALLEZ SPINE, LLC
2009 FREDA LANE
CARDIFF,  CA  92007
Correspondent Contact HARTMUT LOCH
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   MNH   MNI  
Date Received05/17/2005
Decision Date 12/09/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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