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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 K040401
Device Name LANX ANTERIOR CERVIAL PLATE SYSTEM
Applicant
Lanx, LLC
200 Gregory Lane Suite C-100
Pleasant Hill,  CA  94523 -3389
Applicant Contact DAVID W SCHLERF
Correspondent
Lanx, LLC
200 Gregory Lane Suite C-100
Pleasant Hill,  CA  94523 -3389
Correspondent Contact DAVID W SCHLERF
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received02/17/2004
Decision Date 04/12/2004
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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