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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 K953915
Device Name MOSS MIAMI SPINAL SYSTEM (ANTERIOR USE)
Applicant
Depuy, Inc.
700 Orthopaedic Dr., P.O. Box 988
Warsaw,  IN  46581 -0988
Applicant Contact CHERYL HASTINGS
Correspondent
Depuy, Inc.
700 Orthopaedic Dr., P.O. Box 988
Warsaw,  IN  46581 -0988
Correspondent Contact CHERYL HASTINGS
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Codes
KWP   KWQ  
Date Received08/21/1995
Decision Date 02/15/1996
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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