Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Auxilock Draw Tight Suture-Based Anchor

K-Number: K213109 · 2022-08-22

ApplicantAuxein Medical Private Limited
Decision Date2022-08-22
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Auxilock Draw Tight Suture-Based Anchor is a medical device manufactured by Auxein Medical Private Limited. It received FDA 510(k) clearance on 2022-08-22 under approval number K213109. 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 Draw Tight Suture-Based Anchor?

Auxilock Draw Tight Suture-Based Anchor is a medical device that received FDA 510(k) clearance on 2022-08-22. It is manufactured by Auxein Medical Private Limited. The 510(k) number is K213109.

When was Auxilock Draw Tight Suture-Based Anchor approved by the FDA?

Auxilock Draw Tight Suture-Based Anchor received FDA 510(k) clearance on 2022-08-22, under approval number K213109.

What company makes Auxilock Draw Tight Suture-Based Anchor?

Auxilock Draw Tight Suture-Based Anchor is manufactured by Auxein Medical Private Limited.

What is the FDA product code for Auxilock Draw Tight Suture-Based Anchor?

The FDA product code for Auxilock Draw Tight Suture-Based Anchor is MBI.

Related Clinical Trials

NCT06823440 Prevention of CIPN Using Compressive Therapy RECRUITING NCT07019662 Comparing a Suture-based System for the Removal of Arterial and Veinous ECMO Cannulas to the Standard Approach RECRUITING NCT07512336 A Randomized Intra-Patient Controlled Trial of MagnetOs™ Putty vs Autograft in Instrumented Posterolateral Spinal Fusion in Idiopathic Scoliosis Patients NOT_YET_RECRUITING

Related PubMed Literature

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.

↑