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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 K092656
Device Name LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM
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  
Subsequent Product Code
MNI  
Date Received08/28/2009
Decision Date 11/24/2009
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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