Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ARIX Clavicle System

K-Number: K180972 · 2018-10-03

ApplicantJeil Medical Corporation
Decision Date2018-10-03
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARIX Clavicle System is the device name listed in this FDA 510(k) record. The listed applicant is Jeil Medical Corporation. It received FDA 510(k) clearance on 2018-10-03 under 510(k) number K180972. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARIX Clavicle System?

ARIX Clavicle System is a medical device that received FDA 510(k) clearance on 2018-10-03. The listed applicant is Jeil Medical Corporation. The 510(k) number is K180972.

When did ARIX Clavicle System receive FDA 510(k) clearance?

ARIX Clavicle System received FDA 510(k) clearance on 2018-10-03, under 510(k) number K180972.

Who is the listed applicant for ARIX Clavicle System?

The FDA 510(k) record lists Jeil Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARIX Clavicle System?

The FDA product code for ARIX Clavicle System is HRS.

Other records listing Jeil Medical Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252246Leforte MMF SystemK252826ARIX Femur Nail SystemK251431FIX-C PEEK ACIF SA SystemK243973FIX-L PEEK PLIF and T-PLIF SystemK242751ARIX Pectus Bar SystemK242247ARIX Femur Nail System

View all 35 devices →

Related Devices (Code: HRS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.K261511Xpert AnkleNewclip TechnicsK261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )TriMed, Inc.K261191Alians Elbow SNewclip TechnicsK261054RibPlate SystemStryker Leibinger GmbH & Co KG

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑