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 a medical device manufactured by Jeil Medical Corporation. It received FDA 510(k) clearance on 2018-10-03 under approval 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. It is manufactured by Jeil Medical Corporation. The 510(k) number is K180972.
When was ARIX Clavicle System approved by the FDA?
ARIX Clavicle System received FDA 510(k) clearance on 2018-10-03, under approval number K180972.
What company makes ARIX Clavicle System?
ARIX Clavicle System is manufactured by Jeil Medical Corporation.
What is the FDA product code for ARIX Clavicle System?
The FDA product code for ARIX Clavicle System is HRS.
Other Devices by Jeil Medical Corporation
Related Devices (Code: HRS)
K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc.
K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc.
K162974Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation
K163007Biomet Microfixation SternaLock 360 Sternal Closure SystemBiomet Microfixation
K161696aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5Aap Implantate AG
K161747LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5Aap Implantate AG
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.