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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 K140759
Device Name BENGAL SYSTEM, BENGAL STACKABLE SYSTEM, CONCORDE BULLET LUMBAR, CONCORDE INLINE LUMBAR, COUGAR SYSTEM, COUGAR LS LATERAL
Applicant
Medos International SARL
325 Paramount Dr.
Raynham,  MA  02767
Applicant Contact LINDA BERNIER
Correspondent
Medos International SARL
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact LINDA BERNIER
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Codes
MQP   ODP  
Date Received03/26/2014
Decision Date 06/13/2014
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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