Cleared Traditional

Tibia and Fibula System

K213059 · Auxein Medical Private Limited · Orthopedic
Jan 2023
Decision
492d
Days
Class 2
Risk

About This 510(k) Submission

K213059 is an FDA 510(k) clearance for the Tibia and Fibula 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 January 27, 2023, 492 days after receiving the submission on September 22, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K213059 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 2021
Decision Date January 27, 2023
Days to Decision 492 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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