Cleared Traditional

Stryker Resorbable Fixation System

K230733 · Stryker Leibinger GmbH & Co KG · Dental
Aug 2023
Decision
142d
Days
Class 2
Risk

About This 510(k) Submission

K230733 is an FDA 510(k) clearance for the Stryker Resorbable Fixation 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 August 5, 2023, 142 days after receiving the submission on March 16, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.4760.

Submission Details

510(k) Number K230733 FDA.gov
FDA Decision Cleared SESE
Date Received March 16, 2023
Decision Date August 05, 2023
Days to Decision 142 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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