Cleared Traditional

ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System

K201259 · Wrightmedicaltechnologyinc · Orthopedic
Jan 2021
Decision
242d
Days
Class 2
Risk

About This 510(k) Submission

K201259 is an FDA 510(k) clearance for the ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Wrightmedicaltechnologyinc (Memphis, US). The FDA issued a Cleared decision on January 8, 2021, 242 days after receiving the submission on May 11, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K201259 FDA.gov
FDA Decision Cleared SESE
Date Received May 11, 2020
Decision Date January 08, 2021
Days to Decision 242 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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