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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 Intervertebral Body
510(k) Number K092765
Device Name LANX ANTERIOR PLATING SYSTEM
Applicant
LANX, INC.
390 INTERLOCKEN CRESCENT
SUITE 890
BROOMFIELD,  CO  80021
Applicant Contact MICHAEL FUNK
Correspondent
LANX, INC.
390 INTERLOCKEN CRESCENT
SUITE 890
BROOMFIELD,  CO  80021
Correspondent Contact MICHAEL FUNK
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received09/09/2009
Decision Date 04/07/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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