Cleared Traditional

EVOS Patella Plates

K240487 · Smith & Nephew · Orthopedic
Sep 2024
Decision
196d
Days
Class 2
Risk

About This 510(k) Submission

K240487 is an FDA 510(k) clearance for the EVOS Patella Plates, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Smith & Nephew (Memphus, US). The FDA issued a Cleared decision on September 3, 2024, 196 days after receiving the submission on February 20, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K240487 FDA.gov
FDA Decision Cleared SESE
Date Received February 20, 2024
Decision Date September 03, 2024
Days to Decision 196 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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