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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name appliance, fixation, spinal intervertebral body
510(k) Number K072546
Device Name SWIFT PLUS ANTERIOR CERVICAL PLATE SYSTEM
Applicant
DEPUY SPINE,INC
325 PARAMONT DRIVE
RAYNHAM,  MA  02767
Applicant Contact FRANK S JURCZAK
Correspondent
DEPUY SPINE,INC
325 PARAMONT DRIVE
RAYNHAM,  MA  02767
Correspondent Contact FRANK S JURCZAK
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received09/10/2007
Decision Date 10/05/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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