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FDA 510(k)

Auxilock Titanium Screw-In Suture Anchor

K-Number: K213104 · 2022-07-29

ApplicantAuxein Medical Private Limited
Decision Date2022-07-29
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Auxilock Titanium Screw-In Suture Anchor is a medical device manufactured by Auxein Medical Private Limited. It received FDA 510(k) clearance on 2022-07-29 under approval number K213104. 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 Titanium Screw-In Suture Anchor?

Auxilock Titanium Screw-In Suture Anchor is a medical device that received FDA 510(k) clearance on 2022-07-29. It is manufactured by Auxein Medical Private Limited. The 510(k) number is K213104.

When was Auxilock Titanium Screw-In Suture Anchor approved by the FDA?

Auxilock Titanium Screw-In Suture Anchor received FDA 510(k) clearance on 2022-07-29, under approval number K213104.

What company makes Auxilock Titanium Screw-In Suture Anchor?

Auxilock Titanium Screw-In Suture Anchor is manufactured by Auxein Medical Private Limited.

What is the FDA product code for Auxilock Titanium Screw-In Suture Anchor?

The FDA product code for Auxilock Titanium Screw-In Suture Anchor is MBI.

Related Clinical Trials

NCT06636136 Transtibial Osseointegration RECRUITING

Related PubMed Literature

PMID: 41487949 Verification, validation, and uncertainty quantification of finite element analysis results for pedicle screw assemblies under ASTM F1717 flexion and extension testing. Frontiers in bioengineering and biotechnology (2025) PMID: 40868376 Correlation Analysis of Suture Anchor Pull-Out Strength with Cortical Bone Thickness and Cancellous Bone Density on a Finite Element Model. Bioengineering (Basel, Switzerland) (2025)

Other Devices by Auxein Medical Private Limited

K192003Auxein Nailing System K210792Auxein Nailing System K203029Auxilock Titanium Interference Screw K213110AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In Anchor K213018Auxilock GFS Mini, GFS II Large, and GFS Ultimate K213108Humerus & Ulna System

View all 12 devices →

Related Devices (Code: MBI)

K163034SUTUREFIX Curved Suture AnchorSmith and Nephew, Inc. K162198GFS UltimateParcus Medical, LLC K162386KATOR Suture AnchorKator, LLC K161033AFX™ Femoral Implant With InserterCayenne Medical, Inc. K160996Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mmDunamis, LLC K161001MILAGRO ADVANCE PEEK Interference ScrewMedos International SARL

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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