MOSS MIAMI SPINAL SYSTEM

Appliance, Fixation, Spinal Interlaminal

DEPUY, INC.

The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Moss Miami Spinal System.

Pre-market Notification Details

Device IDK962628
510k NumberK962628
Device Name:MOSS MIAMI SPINAL SYSTEM
ClassificationAppliance, Fixation, Spinal Interlaminal
Applicant DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw,  IN  46581 -0988
ContactCheryl Hastings
CorrespondentCheryl Hastings
DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw,  IN  46581 -0988
Product CodeKWP  
Subsequent Product CodeKWQ
Subsequent Product CodeMNH
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-07-05
Decision Date1997-03-18
Summary:summary

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