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FDA 510(k)

Auxilock GFS Mini, GFS II Large, and GFS Ultimate

K-Number: K213018 · 2022-11-18

ApplicantAuxein Medical Private Limited
Decision Date2022-11-18
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Auxilock GFS Mini, GFS II Large, and GFS Ultimate 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 2022-11-18 under 510(k) number K213018. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Auxilock GFS Mini, GFS II Large, and GFS Ultimate?

Auxilock GFS Mini, GFS II Large, and GFS Ultimate is a medical device that received FDA 510(k) clearance on 2022-11-18. The listed applicant is Auxein Medical Private Limited. The 510(k) number is K213018.

When did Auxilock GFS Mini, GFS II Large, and GFS Ultimate receive FDA 510(k) clearance?

Auxilock GFS Mini, GFS II Large, and GFS Ultimate received FDA 510(k) clearance on 2022-11-18, under 510(k) number K213018.

Who is the listed applicant for Auxilock GFS Mini, GFS II Large, and GFS Ultimate?

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 Auxilock GFS Mini, GFS II Large, and GFS Ultimate?

The FDA product code for Auxilock GFS Mini, GFS II Large, and GFS Ultimate is MBI.

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 AnchorK213108Humerus & Ulna SystemK213014Varixis Elbow SystemK213109Auxilock Draw Tight Suture-Based Anchor

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Related Devices (Code: MBI)

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.

K262047Grappler Suture Anchor SystemParagon 28, Inc.K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker EndoscopyK261770Suture Button Repair SystemSkeletal Dynamics, Inc.K261632Thunderbolt SystemResponsive Arthroscopy, Inc.K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)Smith & Nephew, Inc.K260018Arthrex FiberButtonArthrex, Inc.

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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