Cleared Special

Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching)

K231326 · Osteonic Co., Ltd. · Orthopedic

May 2023

Decision

23d

Days

Class 2

Risk

About This 510(k) Submission

K231326 is an FDA 510(k) clearance for the Fix2Lock(Biocomposite medial, 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 May 31, 2023, 23 days after receiving the submission on May 8, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K231326 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 08, 2023
Decision Date	May 31, 2023
Days to Decision	23 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF