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

Cleared Feb 26, 2026

Aster

K254182 · KWQ

Orthopedic · 65d

Cleared May 29, 2025

SIGNEX

K243469 · HRS

Orthopedic · 202d

Cleared Dec 03, 2024

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

K243467 · MAI

Orthopedic · 25d

Cleared Dec 03, 2024

Fix2Lock (PEEK Self Punching)

K243470 · MBI

Orthopedic · 25d

Cleared Jun 11, 2024

SIGNEX

K230546 · HRS

Orthopedic · 469d

Cleared Dec 26, 2023

Suture Wing

K233659 · MBI

Orthopedic · 41d

Cleared Jun 07, 2023

Fix2Lock(PEEK Self Punching)

K231322 · MBI

Orthopedic · 30d

Cleared May 31, 2023

Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching)

K231326 · MAI

Orthopedic · 23d

Cleared Aug 27, 2021

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

Cleared Jun 07, 2021

Suture Wing

K202663 · MBI

Orthopedic · 266d

Cleared Jun 04, 2021

Fix2Lock (PEEK Self Punching)

K202763 · MBI

Orthopedic · 256d