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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 Interlaminal
510(k) Number K131156
Device Name LANX SPINAL FIXATION SYSTEM
Applicant
Lanx, Inc.
310 Interlocken Pkwy. Suite 120
Broomfield,  CO  80021
Applicant Contact MICHAEL MEDINA
Correspondent
Lanx, Inc.
310 Interlocken Pkwy. Suite 120
Broomfield,  CO  80021
Correspondent Contact MICHAEL MEDINA
Regulation Number888.3050
Classification Product Code
KWP  
Date Received04/24/2013
Decision Date 05/24/2013
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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