E-Z LINK CROSS CONNECTOR

Appliance, Fixation, Spinal Interlaminal

DEPUY ACROMED

The following data is part of a premarket notification filed by Depuy Acromed with the FDA for E-z Link Cross Connector.

Pre-market Notification Details

Device IDK001372
510k NumberK001372
Device Name:E-Z LINK CROSS CONNECTOR
ClassificationAppliance, Fixation, Spinal Interlaminal
Applicant DEPUY ACROMED 325 PARAMOUNT DR. Raynham,  MA  02767 -0350
ContactKaren F Jurczak
CorrespondentKaren F Jurczak
DEPUY ACROMED 325 PARAMOUNT DR. Raynham,  MA  02767 -0350
Product CodeKWP  
Subsequent Product CodeKWQ
Subsequent Product CodeMNH
Subsequent Product CodeMNI
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-05-01
Decision Date2000-07-27

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.