Cleared Special

DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System

K203414 · DePuy Synthes · Orthopedic
Dec 2020
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K203414 is an FDA 510(k) clearance for the DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by DePuy Synthes (19380, US). The FDA issued a Cleared decision on December 16, 2020, 27 days after receiving the submission on November 19, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K203414 FDA.gov
FDA Decision Cleared SESE
Date Received November 19, 2020
Decision Date December 16, 2020
Days to Decision 27 days
Submission Type Special
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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