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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, cervical
510(k) Number K120517
Device Name DEPUY PULSE CERVICAL CAGE SYSTEM
Applicant
MEDOS INTERNATIONAL SARL
325 PARAMOUNT DR
RAYNHAM,  MA  02767
Applicant Contact EUGENE BANG
Correspondent
MEDOS INTERNATIONAL SARL
325 PARAMOUNT DR
RAYNHAM,  MA  02767
Correspondent Contact EUGENE BANG
Regulation Number888.3080
Classification Product Code
ODP  
Date Received02/21/2012
Decision Date 04/26/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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