Cleared Traditional

DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long

K163046 · DePuy Synthes · Orthopedic
Feb 2017
Decision
100d
Days
Class 2
Risk

About This 510(k) Submission

K163046 is an FDA 510(k) clearance for the DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by DePuy Synthes (19380, US). The FDA issued a Cleared decision on February 9, 2017, 100 days after receiving the submission on November 1, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K163046 FDA.gov
FDA Decision Cleared SESE
Date Received November 01, 2016
Decision Date February 09, 2017
Days to Decision 100 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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