Tibia and Fibula System
K-Number: K213059 · 2023-01-27
ApplicantAuxein Medical Private Limited
Decision Date2023-01-27
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Tibia and Fibula System is a medical device manufactured by Auxein Medical Private Limited. It received FDA 510(k) clearance on 2023-01-27 under approval number K213059. 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 Tibia and Fibula System?
Tibia and Fibula System is a medical device that received FDA 510(k) clearance on 2023-01-27. It is manufactured by Auxein Medical Private Limited. The 510(k) number is K213059.
When was Tibia and Fibula System approved by the FDA?
Tibia and Fibula System received FDA 510(k) clearance on 2023-01-27, under approval number K213059.
What company makes Tibia and Fibula System?
Tibia and Fibula System is manufactured by Auxein Medical Private Limited.
What is the FDA product code for Tibia and Fibula System?
The FDA product code for Tibia and Fibula System is HRS.
Other Devices by Auxein Medical Private Limited
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.