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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 K962486
Device Name DEPUY MOTECH ANTERIOR COMPRESSION PLATE SYSTEM
Applicant
Depuy, Inc.
700 Orthopaedic Dr.
Warsaw,  IN  46581
Applicant Contact CHERYL HASTINGS
Correspondent
Depuy, Inc.
700 Orthopaedic Dr.
Warsaw,  IN  46581
Correspondent Contact CHERYL HASTINGS
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received06/26/1996
Decision Date 12/27/1996
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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