Cleared Traditional

SIGNEX

K230546 · Osteonic Co., Ltd. · Orthopedic
Jun 2024
Decision
469d
Days
Class 2
Risk

About This 510(k) Submission

K230546 is an FDA 510(k) clearance for the SIGNEX, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Osteonic Co., Ltd. (Guro-Gu, KR). The FDA issued a Cleared decision on June 11, 2024, 469 days after receiving the submission on February 28, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K230546 FDA.gov
FDA Decision Cleared SESE
Date Received February 28, 2023
Decision Date June 11, 2024
Days to Decision 469 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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