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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, Lumbar
510(k) Number K083815
Device Name LANX FUSION SYSTEM
Applicant
Lanx, Inc.
390 Interlocken Crescent
Suite 890
Broomfield,  CO  80021
Applicant Contact Alan Burkholder
Correspondent
Lanx, Inc.
390 Interlocken Crescent
Suite 890
Broomfield,  CO  80021
Correspondent Contact Alan Burkholder
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Codes
MQP   ODP  
Date Received12/22/2008
Decision Date 04/20/2009
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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