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Osteonic Co., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
20
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K254182AsterFebruary 26, 2026
K243469SIGNEXMay 29, 2025
K243470Fix2Lock (PEEK Self Punching)December 3, 2024
K243467Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)December 3, 2024
K230546SIGNEXJune 11, 2024
K233659Suture WingDecember 26, 2023
K231322Fix2Lock(PEEK Self Punching)June 7, 2023
K231326Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching)May 31, 2023
K210360Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro Plating System-PaJanuary 27, 2022
K211992Ortho MI SystemOctober 15, 2021
K210122Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)August 27, 2021
K202806Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)June 17, 2021
K202663Suture WingJune 7, 2021
K202763Fix2Lock (PEEK Self Punching)June 4, 2021
K202883Sterile bone screw (PEEK ACL screw)November 25, 2020
K190811Optimus NEURO System - Sterile KitNovember 27, 2019
K183352Optimus Neuro SystemJanuary 2, 2019
K160363OPTIMUS CMF SYSTEMOctober 20, 2016
K141911OPTIMUS NEURO SYSTEMFebruary 10, 2015
K140037OPTIMUS CMF SYSTEMJanuary 20, 2015