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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 Interlaminal
510(k) Number K974573
Device Name DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM
Applicant
Depuy, Inc.
700 Orthopaedic Dr.
Warsaw,  IN  46581
Applicant Contact CHERYL K HASTINGS
Correspondent
Depuy, Inc.
700 Orthopaedic Dr.
Warsaw,  IN  46581
Correspondent Contact CHERYL K HASTINGS
Regulation Number888.3050
Classification Product Code
KWP  
Subsequent Product Codes
KWQ   MNH  
Date Received12/08/1997
Decision Date 02/18/1998
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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