TIMX LOW BACK SYSTEM

Orthosis, Spinal Pedicle Fixation

DEPUY MOTECH ACROMED

The following data is part of a premarket notification filed by Depuy Motech Acromed with the FDA for Timx Low Back System.

Pre-market Notification Details

Device IDK984348
510k NumberK984348
Device Name:TIMX LOW BACK SYSTEM
ClassificationOrthosis, Spinal Pedicle Fixation
Applicant DEPUY MOTECH ACROMED 3303 CARNEGIE AVE. Cleveland,  OH  44115
ContactPam Corsillo
CorrespondentPam Corsillo
DEPUY MOTECH ACROMED 3303 CARNEGIE AVE. Cleveland,  OH  44115
Product CodeMNI  
Subsequent Product CodeKWP
Subsequent Product CodeMNH
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-12-04
Decision Date1999-01-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10705034241463 K984348 000
10705034005126 K984348 000
10705034005119 K984348 000
10705034005096 K984348 000
10705034005072 K984348 000
10705034005065 K984348 000
10705034005102 K984348 000
10705034005089 K984348 000
10705034005058 K984348 000

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