Cleared Special

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

K243467 · Osteonic Co., Ltd. · Orthopedic

Dec 2024

Decision

25d

Days

Class 2

Risk

About This 510(k) Submission

K243467 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. (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 888.3030.

Submission Details

510(k) Number	K243467 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