Cleared Traditional

DePuy Synthes MatrixSTERNUM Fixation System

K233967 · Synthes GmbH · Orthopedic
May 2024
Decision
146d
Days
Class 2
Risk

About This 510(k) Submission

K233967 is an FDA 510(k) clearance for the DePuy Synthes MatrixSTERNUM Fixation System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Synthes GmbH (Zuchwil, CH). The FDA issued a Cleared decision on May 9, 2024, 146 days after receiving the submission on December 15, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K233967 FDA.gov
FDA Decision Cleared SESE
Date Received December 15, 2023
Decision Date May 09, 2024
Days to Decision 146 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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