Cleared Traditional

Auxilock GFS Mini, GFS II Large, and GFS Ultimate

K213018 · Auxein Medical Private Limited · Orthopedic
Nov 2022
Decision
424d
Days
Class 2
Risk

About This 510(k) Submission

K213018 is an FDA 510(k) clearance for the Auxilock GFS Mini, GFS II Large, and GFS Ultimate, 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 November 18, 2022, 424 days after receiving the submission on September 20, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K213018 FDA.gov
FDA Decision Cleared SESE
Date Received September 20, 2021
Decision Date November 18, 2022
Days to Decision 424 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MBI — Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040