REFLEX ANTERIOR CERVICAL PLATE SYSTEM

Appliance, Fixation, Spinal Intervertebral Body

HOWMEDICA OSTEONICS

The following data is part of a premarket notification filed by Howmedica Osteonics with the FDA for Reflex Anterior Cervical Plate System.

Pre-market Notification Details

Device IDK031702
510k NumberK031702
Device Name:REFLEX ANTERIOR CERVICAL PLATE SYSTEM
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant HOWMEDICA OSTEONICS 59 ROUTE 17 Allendale,  NJ  07401 -1677
ContactKaren Ariemma
CorrespondentKaren Ariemma
HOWMEDICA OSTEONICS 59 ROUTE 17 Allendale,  NJ  07401 -1677
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-06-02
Decision Date2003-08-08
Summary:summary

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