Cleared Traditional

K213109 - Auxilock Draw Tight Suture-Based Anchor (FDA 510(k) Clearance)

K213109 · Auxein Medical Private Limited · Orthopedic device

Aug 2022

Decision

332d

Days

Class 2

Risk

K213109 is an FDA 510(k) clearance for the Auxilock Draw Tight Suture-Based Anchor. This device is classified as a Fastener, Fixation, Nondegradable, Soft Tissue (Class II - Special Controls, product code MBI).

Submitted by Auxein Medical Private Limited (Sonipat, IN). The FDA issued a Cleared decision on August 22, 2022, 332 days after receiving the submission on September 24, 2021.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K213109 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 24, 2021
Decision Date	August 22, 2022
Days to Decision	332 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF