Cleared Special

Stryker Facial iD Plating System

K193143 · Stryker · Dental
Mar 2020
Decision
134d
Days
Class 2
Risk

About This 510(k) Submission

K193143 is an FDA 510(k) clearance for the Stryker Facial iD Plating System, a Plate, Bone (Class II — Special Controls, product code JEY), submitted by Stryker (Portage, US). The FDA issued a Cleared decision on March 26, 2020, 134 days after receiving the submission on November 13, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.4760.

Submission Details

510(k) Number K193143 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 2019
Decision Date March 26, 2020
Days to Decision 134 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code JEY — Plate, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4760

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