Medical Device Manufacturer · KR , Seoul

Osteonic Co., Ltd.

20 submissions · 20 cleared · Since 2015
20
Total
20
Cleared
0
Denied

Osteonic Co., Ltd. — FDA 510(k) Submissions

Osteonic Co., Ltd. has submitted 20 FDA 510(k) premarket notifications since 2015, of which 20 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Fastener, Fixation, Nondegradable, Soft Tissue, Plate, Cranioplasty, Preformed, Alterable, Fastener, Fixation, Biodegradable, Soft Tissue, Plate, Bone, Plate, Fixation, Bone . Use the specialty filter in the sidebar to narrow results.

20 devices
1–20 of 20
Aster
K254182 · KWQ Appliance, Fixation,... · Orthopedic
Feb 2026 65d
SIGNEX
K243469 · HRS Plate, Fixation, Bone · Orthopedic
May 2025 202d
Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)
K243467 · MAI Fastener, Fixation,... · Orthopedic
Dec 2024 25d
Fix2Lock (PEEK Self Punching)
K243470 · MBI Fastener, Fixation,... · Orthopedic
Dec 2024 25d
SIGNEX
K230546 · HRS Plate, Fixation, Bone · Orthopedic
Jun 2024 469d
Suture Wing
K233659 · MBI Fastener, Fixation,... · Orthopedic
Dec 2023 41d
Fix2Lock(PEEK Self Punching)
K231322 · MBI Fastener, Fixation,... · Orthopedic
Jun 2023 30d
Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching)
K231326 · MAI Fastener, Fixation,... · Orthopedic
May 2023 23d
Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro Plating System-Packaging unit(NSP-001 and 10 models), Neuro Plating System-Sterile Kit(TCN-011 and 69 models), Neuro Plating System-Screws(N15A03 and 11 models)
K210360 · GWO Plate, Cranioplasty,... · Neurology
Jan 2022 353d
Ortho MI System
K211992 · OAT Implant, Endosseous,... · Dental
Oct 2021 109d
Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)
K210122 · MAI Fastener, Fixation,... · Orthopedic
Aug 2021 220d
Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)
K202806 · MAI Fastener, Fixation,... · Orthopedic
Jun 2021 267d
Suture Wing
K202663 · MBI Fastener, Fixation,... · Orthopedic
Jun 2021 266d
Fix2Lock (PEEK Self Punching)
K202763 · MBI Fastener, Fixation,... · Orthopedic
Jun 2021 256d
Sterile bone screw (PEEK ACL screw)
K202883 · MBI Fastener, Fixation,... · Orthopedic
Nov 2020 58d
Optimus NEURO System - Sterile Kit
K190811 · GWO Plate, Cranioplasty,... · Neurology
Nov 2019 243d
Optimus Neuro System
K183352 · GWO Plate, Cranioplasty,... · Neurology
Jan 2019 30d
OPTIMUS CMF SYSTEM
K160363 · JEY Plate, Bone · Dental
Oct 2016 254d
OPTIMUS NEURO SYSTEM
K141911 · GWO Plate, Cranioplasty,... · Neurology
Feb 2015 210d
OPTIMUS CMF SYSTEM
K140037 · JEY Plate, Bone · Dental
Jan 2015 378d
Filters