Cleared Traditional

SIGNEX

K243469 · Osteonic Co., Ltd. · Orthopedic
May 2025
Decision
202d
Days
Class 2
Risk

About This 510(k) Submission

K243469 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. (Seoul, KR). The FDA issued a Cleared decision on May 29, 2025, 202 days after receiving the submission on November 8, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K243469 FDA.gov
FDA Decision Cleared SESE
Date Received November 08, 2024
Decision Date May 29, 2025
Days to Decision 202 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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