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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 K073348
Device Name LUCENT MAGNUM
Applicant
Spinal Elements, Inc.
2744 Loker Ave. W. Suite 100
Carlsbad,  CA  92010
Applicant Contact KERRI DIMARTINO
Correspondent
Spinal Elements, Inc.
2744 Loker Ave. W. Suite 100
Carlsbad,  CA  92010
Correspondent Contact KERRI DIMARTINO
Regulation Number888.3080
Classification Product Code
MAX  
Date Received11/29/2007
Decision Date 12/26/2007
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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