DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM

Orthosis, Spondylolisthesis Spinal Fixation

DEPUY ORTHOPAEDICS, INC.

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

Pre-market Notification Details

Device IDK980447
510k NumberK980447
Device Name:DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM
ClassificationOrthosis, Spondylolisthesis Spinal Fixation
Applicant DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw,  IN  46581 -0988
ContactLynnette Whitaker
CorrespondentLynnette Whitaker
DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw,  IN  46581 -0988
Product CodeMNH  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-02-05
Decision Date1998-04-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10705034023601 K980447 000
10705034023595 K980447 000

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