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510(k) K231441

Device
ARIX Ankle System
Applicant
Jeil Medical Corporation
510(k) number
K231441
Product code
HRS
Decision
Substantially Equivalent (SESE)
Decision date
2023-07-17
Date received
2023-05-18
Regulation
888.3030
Classification name
Plate, Fixation, Bone
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Dajung Lee
Address
702,703,704,705,706,804,805,807,812,815-Ho, 55, Digital-Ro34-Gil, Guro-Gu Seoul KR 08378 08378

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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