Osteonic Co., Ltd.
Osteonic Co., Ltd. holds FDA 510(k) medical device clearances, first cleared 2015, most recent 2026.
Top product codes for Osteonic Co., Ltd.
Recent clearances by Osteonic Co., Ltd.
- K254182 — Aster
- K243469 — SIGNEX
- K243467 — Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)
- K243470 — Fix2Lock (PEEK Self Punching)
- K230546 — SIGNEX
- K233659 — Suture Wing
- K231322 — Fix2Lock(PEEK Self Punching)
- K231326 — Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching)
- K210360 — 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)
- K211992 — Ortho MI System
- K210122 — Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)
- K202806 — Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)
- K202663 — Suture Wing
- K202763 — Fix2Lock (PEEK Self Punching)
- K202883 — Sterile bone screw (PEEK ACL screw)
- K190811 — Optimus NEURO System - Sterile Kit
- K183352 — Optimus Neuro System
- K160363 — OPTIMUS CMF SYSTEM
- K141911 — OPTIMUS NEURO SYSTEM
- K140037 — OPTIMUS CMF SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.