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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 K122896
Device Name COUGAR LS 15 LATERAL CAGE SYSTEM
Applicant
Medos International SARL
325 Paramount Dr.
Raynham,  MA  02767
Applicant Contact KIRSTEN LEHMULLER
Correspondent
Medos International SARL
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact KIRSTEN LEHMULLER
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Code
MQP  
Date Received09/21/2012
Decision Date 10/18/2012
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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