Cleared Traditional

K213104 - Auxilock Titanium Screw-In Suture Anchor
(FDA 510(k) Clearance)

K213104 · Auxein Medical Private Limited · Orthopedic device

Jul 2022

Decision

308d

Days

Class 2

Risk

K213104 is an FDA 510(k) clearance for the Auxilock Titanium Screw-In Suture 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 July 29, 2022, 308 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	K213104 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 24, 2021
Decision Date	July 29, 2022
Days to Decision	308 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF