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FDA 510(k)

Varixis Elbow System

K-Number: K213014 · 2022-10-03

ApplicantAuxein Medical Private Limited
Decision Date2022-10-03
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Varixis Elbow System is the device name listed in this FDA 510(k) record. The listed applicant is Auxein Medical Private Limited. It received FDA 510(k) clearance on 2022-10-03 under 510(k) number K213014. 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 Varixis Elbow System?

Varixis Elbow System is a medical device that received FDA 510(k) clearance on 2022-10-03. The listed applicant is Auxein Medical Private Limited. The 510(k) number is K213014.

When did Varixis Elbow System receive FDA 510(k) clearance?

Varixis Elbow System received FDA 510(k) clearance on 2022-10-03, under 510(k) number K213014.

Who is the listed applicant for Varixis Elbow System?

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

What is the FDA product code for Varixis Elbow System?

The FDA product code for Varixis Elbow System is HRS.

Other records listing Auxein Medical Private Limited 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.

K221787Auxein's DHS/DCS Plate SystemK213059Tibia and Fibula SystemK213110AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In AnchorK213018Auxilock GFS Mini, GFS II Large, and GFS UltimateK213108Humerus & Ulna SystemK213109Auxilock Draw Tight Suture-Based Anchor

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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.

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