Cleared Traditional

Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws

K213126 · Smith & Nephew, Inc. · Orthopedic
Sep 2022
Decision
367d
Days
Class 2
Risk

About This 510(k) Submission

K213126 is an FDA 510(k) clearance for the Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws, a Device, Fixation, Proximal Femoral, Implant (Class II — Special Controls, product code JDO), submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on September 29, 2022, 367 days after receiving the submission on September 27, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K213126 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 2021
Decision Date September 29, 2022
Days to Decision 367 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JDO — Device, Fixation, Proximal Femoral, Implant
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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