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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 K120966
Device Name DEPUY PULSE LUMBAR CAGE SYSTEM
Applicant
Medos International SARL
325 Paramount Dr.
Raynham,  MA  02767
Applicant Contact ROBIN DINARDO
Correspondent
Medos International SARL
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact ROBIN DINARDO
Regulation Number888.3080
Classification Product Code
MAX  
Date Received03/30/2012
Decision Date 07/03/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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