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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 K103488
Device Name CONCORDE BULLET CAGE SYSTEM
Applicant
Johnson and Johnson
325 Paramount Dr.
Raynham,  MA  02767
Applicant Contact KEVIN G STEVENS
Correspondent
Johnson and Johnson
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact KEVIN G STEVENS
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Codes
MQP   ODP  
Date Received11/26/2010
Decision Date 03/02/2011
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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