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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 K110632
Device Name LUCENT OR LUCENT MAGNUM
Applicant
Spinal Elements, Inc.
2744 Loker Ave. W. Suite 100
Carlsbad,  CA  90210
Applicant Contact BENJAMIN A KIMBALL
Correspondent
Spinal Elements, Inc.
2744 Loker Ave. W. Suite 100
Carlsbad,  CA  90210
Correspondent Contact BENJAMIN A KIMBALL
Regulation Number888.3080
Classification Product Code
MAX  
Date Received03/04/2011
Decision Date 05/23/2012
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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