Cleared Traditional

Auxein Nailing System

K192003 · Auxein Medical Private Limited · Orthopedic
Jun 2020
Decision
320d
Days
Class 2
Risk

About This 510(k) Submission

K192003 is an FDA 510(k) clearance for the Auxein Nailing System, a Nail, Fixation, Bone (Class II — Special Controls, product code JDS), submitted by Auxein Medical Private Limited (Sonipat, IN). The FDA issued a Cleared decision on June 10, 2020, 320 days after receiving the submission on July 26, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K192003 FDA.gov
FDA Decision Cleared SESE
Date Received July 26, 2019
Decision Date June 10, 2020
Days to Decision 320 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JDS — Nail, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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