Cleared Special

Fix2Lock (PEEK Self Punching)

K243470 · Osteonic Co., Ltd. · Orthopedic
Dec 2024
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K243470 is an FDA 510(k) clearance for the Fix2Lock (PEEK Self Punching), 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 3, 2024, 25 days after receiving the submission on November 8, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K243470 FDA.gov
FDA Decision Cleared SESE
Date Received November 08, 2024
Decision Date December 03, 2024
Days to Decision 25 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