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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 K103040
Device Name LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)
Applicant
Lanx, LLC
390 Interlocken Crescent
Suite 890
Broomfield,  CO  80021
Applicant Contact DAMON BELLONI
Correspondent
Lanx, LLC
390 Interlocken Crescent
Suite 890
Broomfield,  CO  80021
Correspondent Contact DAMON BELLONI
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   MNI  
Date Received10/13/2010
Decision Date 02/08/2011
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
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