Nitinol Compression Plating System
FDA 510(k) K143023 · Biomedical Enterprises, Inc.
510(k) numberK143023
Submission
- Device name
- Nitinol Compression Plating System
- Applicant
- Biomedical Enterprises, Inc.
San Antonio, TX, US - Received
- October 21, 2014
- Decision date
- January 16, 2015
- 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 |
|---|---|---|
| K153573 | ConvergeHRS · Traditional | 08/11/2016SE |
| K150125 | Elite Nitinol Fixation SystemJDR · Traditional | 05/11/2015SE |
| K142292 | Speed, Speed Shift, Speed Titan, Speed ArcJDR · Traditional | 11/17/2014SE |
| K133270 | Speed ArcJDR · Traditional | 04/17/2014SE |
| K133520 | Hammerlock 2HTY · Traditional | 01/09/2014SE |
| K124022 | Speed ShiftJDR · Traditional | 05/14/2013SE |
| K061385 | Osstaple, Ossplate, OssforceKWQ · Traditional | 05/30/2007SE |
| K023488 | Osstaple, CraniofacialJEY · Special | 10/31/2002SE |
| K023486 | Osstaple, MaxillofacialJEY · Special | 10/31/2002SE |
Questions and answers
When was Nitinol Compression Plating System cleared by the FDA?
Nitinol Compression Plating System (K143023) received a 510(k) decision of Substantially Equivalent on January 16, 2015, 87 days after the submission was received.
What is the product code of K143023?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.