Cleared Special

Suture Wing

K233659 · Osteonic Co., Ltd. · Orthopedic
Dec 2023
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K233659 is an FDA 510(k) clearance for the Suture Wing, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Osteonic Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on December 26, 2023, 41 days after receiving the submission on November 15, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K233659 FDA.gov
FDA Decision Cleared SESE
Date Received November 15, 2023
Decision Date December 26, 2023
Days to Decision 41 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MBI — Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040