Cleared Traditional

Universal CMF System

K221855 · Stryker Leibinger GmbH & Co KG · Dental
Nov 2022
Decision
135d
Days
Class 2
Risk

About This 510(k) Submission

K221855 is an FDA 510(k) clearance for the Universal CMF System, a Plate, Bone (Class II — Special Controls, product code JEY), submitted by Stryker Leibinger GmbH & Co KG (Freiburg, DE). The FDA issued a Cleared decision on November 9, 2022, 135 days after receiving the submission on June 27, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.4760.

Submission Details

510(k) Number K221855 FDA.gov
FDA Decision Cleared SESE
Date Received June 27, 2022
Decision Date November 09, 2022
Days to Decision 135 days
Submission Type Traditional
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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