Cleared Traditional

PRO Plating System, Stryker Trauma Pelvic Set (Matta)

K223772 · Stryker GmbH · Orthopedic
Apr 2023
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K223772 is an FDA 510(k) clearance for the PRO Plating System, Stryker Trauma Pelvic Set (Matta), 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 7, 2023, 112 days after receiving the submission on December 16, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K223772 FDA.gov
FDA Decision Cleared SESE
Date Received December 16, 2022
Decision Date April 07, 2023
Days to Decision 112 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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