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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 K933881
Device Name DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM
Applicant
Depuy, Inc.
P.O. Box 988
700 Orthopaedic Dr.
Warsaw,  IN  46581
Applicant Contact CHERYL HASTINGS
Correspondent
Depuy, Inc.
P.O. Box 988
700 Orthopaedic Dr.
Warsaw,  IN  46581
Correspondent Contact CHERYL HASTINGS
Regulation Number888.3050
Classification Product Code
KWP  
Date Received08/10/1993
Decision Date 07/12/1994
Decision Substantially Equivalent (SESE)
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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