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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Interlaminal
510(k) Number K100191
Device Name LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)
Applicant
Lanx, Inc.
390 Interlocken Crescent
Suite 890
Broomfield,  CO  80021
Applicant Contact ANDREW LAMBORNE
Correspondent
Lanx, Inc.
390 Interlocken Crescent
Suite 890
Broomfield,  CO  80021
Correspondent Contact ANDREW LAMBORNE
Regulation Number888.3050
Classification Product Code
KWP  
Date Received01/22/2010
Decision Date 04/15/2010
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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