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 ID: K212266
• 510k Number: K212266
• Device Name: FIX-C PEEK Anterior Cervical Interbody System
• Classification: Intervertebral 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
• Contact: Dajung Lee
• Correspondent: Dajung 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 Code: ODP
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-07-20
• Decision Date: 2021-12-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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