Cleared Special

Fix2Lock(PEEK Self Punching)

K231322 · Osteonic Co., Ltd. · Orthopedic
Jun 2023
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K231322 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 June 7, 2023, 30 days after receiving the submission on May 8, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K231322 FDA.gov
FDA Decision Cleared SESE
Date Received May 08, 2023
Decision Date June 07, 2023
Days to Decision 30 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