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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Bone Graft, Cervical
510(k) Number K103660
Device Name LANX CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM
Applicant
Lanx, Inc.
390 Interlocken Crescent
Suite 890
Broomfield,  CO  80021
Applicant Contact WILLIAM SANDUL
Correspondent
Lanx, Inc.
390 Interlocken Crescent
Suite 890
Broomfield,  CO  80021
Correspondent Contact WILLIAM SANDUL
Regulation Number888.3080
Classification Product Code
ODP  
Subsequent Product Code
MQP  
Date Received12/15/2010
Decision Date 02/28/2011
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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