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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 Integrated Fixation, Lumbar
510(k) Number K123767
Device Name LANX FUSION SYSTEM- SA
Applicant
Lanx, Inc.
310 Interlocken Pkwy. Suite 120
Broomfield,  CO  80021
Applicant Contact Alan Burkholder
Correspondent
Lanx, Inc.
310 Interlocken Pkwy. Suite 120
Broomfield,  CO  80021
Correspondent Contact Alan Burkholder
Regulation Number888.3080
Classification Product Code
OVD  
Subsequent Product Codes
MAX   MQP   ODP  
Date Received12/07/2012
Decision Date 03/18/2013
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
Recalls CDRH Recalls
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