Cleared Traditional

Fix2Lock (PEEK Self Punching)

K202763 · Osteonic Co., Ltd. · Orthopedic
Jun 2021
Decision
256d
Days
Class 2
Risk

About This 510(k) Submission

K202763 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. (Guro-Gu, KR). The FDA issued a Cleared decision on June 4, 2021, 256 days after receiving the submission on September 21, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K202763 FDA.gov
FDA Decision Cleared SESE
Date Received September 21, 2020
Decision Date June 04, 2021
Days to Decision 256 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