FDA.reportPublic FDA data

510(k) K251431

Device
FIX-C PEEK ACIF SA System
Applicant
Jeil Medical Corporation
510(k) number
K251431
Product code
OVE
Decision
Substantially Equivalent (SESE)
Decision date
2025-06-27
Date received
2025-05-08
Regulation
888.3080
Classification name
Intervertebral Fusion Device With Integrated Fixation, Cervical
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jinwoo Kim
Address
702•703•704•705•706•707•804•805•807•812•815-Ho, 55 Digital-Ro 34-Gil, Guro-Gu Seoul KR 08378 08378

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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