Cleared Traditional

VOLT? Proximal Humerus 3.5 Plating System

K233994 · Synthes GmbH · Orthopedic
Jul 2024
Decision
221d
Days
Class 2
Risk

About This 510(k) Submission

K233994 is an FDA 510(k) clearance for the VOLT? Proximal Humerus 3.5 Plating 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 July 26, 2024, 221 days after receiving the submission on December 18, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K233994 FDA.gov
FDA Decision Cleared SESE
Date Received December 18, 2023
Decision Date July 26, 2024
Days to Decision 221 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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