Cleared Traditional

DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System

K210205 · Synthes USA Products, LLC · Orthopedic
Mar 2021
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K210205 is an FDA 510(k) clearance for the DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Synthes USA Products, LLC (19380, US). The FDA issued a Cleared decision on March 26, 2021, 59 days after receiving the submission on January 26, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K210205 FDA.gov
FDA Decision Cleared SESE
Date Received January 26, 2021
Decision Date March 26, 2021
Days to Decision 59 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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