FIX-C PEEK Anterior Cervical Interbody System

Intervertebral Fusion Device With Bone Graft, Cervical

Jeil Medical Corporation

The following data is part of a premarket notification filed by Jeil Medical Corporation with the FDA for Fix-c Peek Anterior Cervical Interbody System.

Pre-market Notification Details

Device IDK212266
510k NumberK212266
Device Name:FIX-C PEEK Anterior Cervical Interbody System
ClassificationIntervertebral Fusion Device With Bone Graft, Cervical
Applicant Jeil Medical Corporation 702, 703, 704, 705, 706, 804, 805, 807, 812, 815-ho, 55, Digital-ro 34-gil, Guro-gu Seoul,  KR 08378
ContactDajung Lee
CorrespondentDajung Lee
Jeil Medical Corporation 702, 703, 704, 705, 706, 804, 805, 807, 812, 815-ho, 55, Digital-ro 34-gil, Guro-gu Seoul,  KR 08378
Product CodeODP  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-20
Decision Date2021-12-21
Summary:summary

NIH GUDID Devices

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