TDM Plate and Screw System
FDA 510(k) K241128 · Tdm Co., Ltd.
510(k) numberK241128
Submission
- Device name
- TDM Plate and Screw System
- Applicant
- Tdm Co., Ltd.
Gwangju, KR - Received
- April 24, 2024
- Decision date
- December 5, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K230071 | Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail…HSB · Traditional | 08/22/2024SE |
| K240423 | TDM Anterior Cervical Plate SystemKWQ · Traditional | 04/08/2024SE |
| K232115 | TDM Large Bone Plate and Screw SystemHRS · Traditional | 04/05/2024SE |
| K231860 | TDM Screw SystemHWC · Special | 01/18/2024SE |
| K221844 | TDM Lumbar Interbody Fusion Cage SystemMAX · Traditional | 08/17/2022SE |
| K220285 | PINE Pedicle Screw SystemNKB · Traditional | 05/19/2022SE |
| K191057 | Park's Pectus SystemHRS · Traditional | 03/19/2020SE |
| K190391 | TDM Plate and Screw SystemsHRS · Traditional | 11/15/2019SE |
| K190830 | TDM Screw SystemsHWC · Traditional | 09/13/2019SE |
| K171808 | TDM Plate and Screw SystemHRS · Traditional | 03/15/2018SE |
Questions and answers
When was TDM Plate and Screw System cleared by the FDA?
TDM Plate and Screw System (K241128) received a 510(k) decision of Substantially Equivalent on December 5, 2024, 225 days after the submission was received.
What is the product code of K241128?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.