Mr. Gan · haixiao@sungolytest.com · +86 158 2169 5110 · +86 132 4819 8029Mr. Luo · jun.luo@sungoglobal.com · +86 177 5560 4650

K242751

ARIX Pectus Bar System

510(k) number
K242751
Device name
ARIX Pectus Bar System
Applicant
Jeil Medical Corporation KR
Product code
HRS — Plate, Fixation, Bone
Decision date
2025-05-30
Date received
2024-09-12
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain

Also available from FDA: K242751.pdf

Official FDA record: K242751
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.