Signex
FDA 510(k) K230546 · Osteonic Co., Ltd.
510(k) numberK230546
Submission
- Device name
- Signex
- Applicant
- Osteonic Co., Ltd.
Guro-Gu, KR - Received
- February 28, 2023
- Decision date
- June 11, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HRS – Plate, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HRS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261647 | Tempo Plating System; Ultra Compression Screw SystemHRS · Traditional | Pace Surgical | 09/03/2026SE |
| K261830 | FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…HRS · Traditional | Ortler Global Tibbi Gerecler Anonim Sirketi | 08/28/2026SE |
| K262537 | Versalock Sterile Plating SystemHRS · Special | GM Dos Reis Industria e Comercio Ltda. | 08/19/2026SE |
| K260277 | Mikron Trauma Bone Plate& Screw SystemHRS · Traditional | Mikron Makina San. ve Tic. Ltd. Sti. | 08/13/2026SE |
| K261511 | Xpert AnkleHRS · Traditional | Newclip Technics | 07/28/2026SE |
| K261406 | Versalock Proximal Tibial Plating SystemHRS · Traditional | GM Dos Reis Industria e Comercio Ltda. | 07/21/2026SE |
| K262032 | TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…HRS · Special | TriMed, Inc. | 07/16/2026SE |
| K261191 | Alians Elbow SHRS · Traditional | Newclip Technics | 07/08/2026SE |
| K261054 | RibPlate SystemHRS · Traditional | Stryker Leibinger GmbH & Co KG | 07/01/2026SE |
| K261351 | SALGINA 2.5mm Distal Radius SystemHRS · Traditional | Bonebridge AG | 06/26/2026SE |
More from Bonebridge AG
| 510(k) | Device | Decision |
|---|---|---|
| K254182 | AsterKWQ · Traditional | 02/26/2026SE |
| K243469 | SignexHRS · Traditional | 05/29/2025SE |
| K243470 | Fix2Lock (PEEK Self Punching)MBI · Special | 12/03/2024SE |
| K243467 | Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)MAI · Special | 12/03/2024SE |
| K233659 | Suture WingMBI · Special | 12/26/2023SE |
| K231322 | Fix2Lock(PEEK Self Punching)MBI · Special | 06/07/2023SE |
| K231326 | Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching)MAI · Special | 05/31/2023SE |
| K210360 | Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro…GWO · Traditional | 01/27/2022SE |
| K211992 | Ortho MI SystemOAT · Traditional | 10/15/2021SE |
| K210122 | Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)MAI · Traditional | 08/27/2021SE |
Questions and answers
When was Signex cleared by the FDA?
Signex (K230546) received a 510(k) decision of Substantially Equivalent on June 11, 2024, 469 days after the submission was received.
What is the product code of K230546?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.