Osteonic Co., Ltd. - FDA 510(k) Cleared Devices

Osteonic Co., Ltd. is a Seoul-based medical device manufacturer specializing in bone implant and reconstructive implant systems. The company designs metal and biodegradable composite-based products for surgical applications.

Osteonic has received 20 FDA 510(k) clearances from 20 total submissions since 2015. The company's cleared devices span orthopedic, neurology, and dental categories. Most recent clearance occurred in 2026, confirming active regulatory engagement and current market presence.

The company's product portfolio includes orthopedic plating systems, neuro plating systems, and dental implant solutions. Notable cleared devices include the Fix2Lock system, SIGNEX, Suture Wing, and the Neuro Plating System with associated plates and screws. Osteonic maintains a global sales network with partnerships including B.Braun and Zimmer Biomet.

Explore the complete list of cleared device names, product codes, and clearance dates in the database below.

Regulatory submissions have been managed by Wise Company, Inc. and Bt Solutions, Inc..