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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 K082774
Device Name LANX CERVICAL INTERVERTEBRAL BODY FUSION DEVICE
Applicant
LANX, LLC
390 INTERLOCKEN CRESCENT
SUITE 890
BROOMFIELD,  CO  80021
Applicant Contact Alan Burkholder
Correspondent
LANX, LLC
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 Received09/22/2008
Decision Date 10/21/2008
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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