Cleared Traditional

DARCO Locking Bone Plate System

K171852 · Wrightmedicaltechnologyinc · Orthopedic
Sep 2017
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K171852 is an FDA 510(k) clearance for the DARCO Locking Bone Plate System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Wrightmedicaltechnologyinc (Memphis, US). The FDA issued a Cleared decision on September 21, 2017, 92 days after receiving the submission on June 21, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K171852 FDA.gov
FDA Decision Cleared SESE
Date Received June 21, 2017
Decision Date September 21, 2017
Days to Decision 92 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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