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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 K103748
Device Name LAGUNA PEDICLE SCREW SYSTEM
Applicant
Phygen, LLC
2301 Dupont Dr.
Suite 510
Irvine,  CA  92612
Applicant Contact HARTMUT LOCH
Correspondent
Phygen, LLC
2301 Dupont Dr.
Suite 510
Irvine,  CA  92612
Correspondent Contact HARTMUT LOCH
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI  
Date Received12/23/2010
Decision Date 03/02/2011
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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