Medical Device Manufacturer · KR , Seoul

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

20 submissions · 20 cleared · Since 2015

Total

Cleared

Denied

Osteonic Co., Ltd. has 20 FDA 510(k) cleared medical devices. Based in Seoul, KR.

Latest FDA clearance: Feb 2026. Active since 2015. Primary specialty: Orthopedic.

Browse the FDA 510(k) cleared devices submitted by Osteonic Co., Ltd. Filter by specialty or product code using the sidebar.

FDA 510(k) cleared devices by Osteonic Co., Ltd.

20 devices

1-12 of 20

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

K243467 · MAI

Orthopedic · 25d

Cleared Dec 03, 2024

Fix2Lock (PEEK Self Punching)

Fix2Lock(PEEK Self Punching)

K231322 · MBI

Orthopedic · 30d

Cleared May 31, 2023

Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching)

K231326 · MAI

Orthopedic · 23d

Cleared Jan 27, 2022

Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models),...

Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)

K210122 · MAI

Orthopedic · 220d

Cleared Jun 17, 2021

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

K202806 · MAI

Orthopedic · 267d

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

FDA 510(k) cleared devices by Osteonic Co., Ltd.

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