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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spondylolisthesis Spinal Fixation
510(k) Number K972568
Device Name DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM
Applicant
Depuy, Inc.
700 Orthopaedic Dr.
Warsaw,  IN  46581
Applicant Contact VICKIE E ARFORD
Correspondent
Depuy, Inc.
700 Orthopaedic Dr.
Warsaw,  IN  46581
Correspondent Contact VICKIE E ARFORD
Regulation Number888.3070
Classification Product Code
MNH  
Date Received07/10/1997
Decision Date 09/19/1997
Decision Substantially Equivalent (SESE)
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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