Cleared Traditional

Auxein's DHS/DCS Plate System

K221787 · Auxein Medical Private Limited · Orthopedic

Nov 2023

Decision

527d

Days

Class 2

Risk

About This 510(k) Submission

K221787 is an FDA 510(k) clearance for the Auxein's DHS/DCS Plate System, a Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (Class II — Special Controls, product code KTT), submitted by Auxein Medical Private Limited (Sonipat, IN). The FDA issued a Cleared decision on November 30, 2023, 527 days after receiving the submission on June 21, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K221787 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 21, 2022
Decision Date	November 30, 2023
Days to Decision	527 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	KTT — Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3030