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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 K151352
Device Name CONCORDE Bullet Spinal System
Applicant
Medos International SARL
Chemin-Blanc 38
Le Locle,  CH 2400
Applicant Contact JEFFREY SHIFFMAN
Correspondent
Depuy Spine, A Johnson & Johnson Company
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact JEFFREY SHIFFMAN
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Code
MQP  
Date Received05/20/2015
Decision Date 10/08/2015
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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