Cleared Traditional

Suture Wing

K202663 · Osteonic Co., Ltd. · Orthopedic
Jun 2021
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K202663 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. (Guro-Gu, KR). The FDA issued a Cleared decision on June 7, 2021, 266 days after receiving the submission on September 14, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K202663 FDA.gov
FDA Decision Cleared SESE
Date Received September 14, 2020
Decision Date June 07, 2021
Days to Decision 266 days
Submission Type Traditional
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