Cleared Traditional

Humerus & Ulna System

K213108 · Auxein Medical Private Limited · Orthopedic
Nov 2022
Decision
406d
Days
Class 2
Risk

About This 510(k) Submission

K213108 is an FDA 510(k) clearance for the Humerus & Ulna System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Auxein Medical Private Limited (Sonipat, IN). The FDA issued a Cleared decision on November 4, 2022, 406 days after receiving the submission on September 24, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K213108 FDA.gov
FDA Decision Cleared SESE
Date Received September 24, 2021
Decision Date November 04, 2022
Days to Decision 406 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HRS — Plate, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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