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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 K953730
Device Name CODMAN ANTERIOR CERVICAL PLATE SYSTEM
Applicant
Johnson & Johnson Professionals, Inc.
Rte. 202 N.
Raritan,  NJ  08869
Applicant Contact AMY WALTERS
Correspondent
Johnson & Johnson Professionals, Inc.
Rte. 202 N.
Raritan,  NJ  08869
Correspondent Contact AMY WALTERS
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received08/10/1995
Decision Date 11/09/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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