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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 K792352
Device Name SYNTHES CERVICAL VERTABRAE PLATES
Applicant
DePuy Synthes
325 Paramount Dr.
Raynham,  MA  02767
Applicant Contact unknown unknown
Correspondent
DePuy Synthes
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact unknown unknown
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received11/19/1979
Decision Date 12/06/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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