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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 K050060
Device Name LAGUNA PEDICLE SCREW SYSTEM
Applicant
ALLEZ SPINE, LLC
19772 MACARTHUR BLVD.
SUITE 150
IRVINE,  CA  92612
Applicant Contact HARTMUT LOCH
Correspondent
ALLEZ SPINE, LLC
19772 MACARTHUR BLVD.
SUITE 150
IRVINE,  CA  92612
Correspondent Contact HARTMUT LOCH
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   KWQ   MNH  
Date Received01/11/2005
Decision Date 05/04/2005
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
Recalls CDRH Recalls
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