Cleared Traditional

Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)

K202806 · Osteonic Co., Ltd. · Orthopedic

Jun 2021

Decision

267d

Days

Class 2

Risk

About This 510(k) Submission

K202806 is an FDA 510(k) clearance for the Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching), a Fastener, Fixation, Biodegradable, Soft Tissue (Class II — Special Controls, product code MAI), submitted by Osteonic Co., Ltd. (Guro-Gu, KR). The FDA issued a Cleared decision on June 17, 2021, 267 days after receiving the submission on September 23, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K202806 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 23, 2020
Decision Date	June 17, 2021
Days to Decision	267 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF