Cleared Traditional

PeriPRO? Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System

K222381 · Stryker GmbH · Orthopedic
Apr 2023
Decision
265d
Days
Class 2
Risk

About This 510(k) Submission

K222381 is an FDA 510(k) clearance for the PeriPRO? Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Stryker GmbH (Malwah, US). The FDA issued a Cleared decision on April 27, 2023, 265 days after receiving the submission on August 5, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K222381 FDA.gov
FDA Decision Cleared SESE
Date Received August 05, 2022
Decision Date April 27, 2023
Days to Decision 265 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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