The OsteoCentric Bone Plate and Screw System
FDA 510(k) K250494 · OsteoCentric Technologies
510(k) numberK250494
Submission
- Device name
- The OsteoCentric Bone Plate and Screw System
- Applicant
- OsteoCentric Technologies
Logan, UT, US - Received
- February 20, 2025
- Decision date
- March 18, 2025
- 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 |
|---|---|---|
| K250520 | OsteoCentric Navigated Instruments SystemOLO · Traditional | 10/27/2025SE |
| K251913 | OsteoCentric® UnifiMI® TCS Plating SystemHRS · Special | 08/16/2025SE |
| K242691 | OsteoCentric Technologies Cannulated Fasteners and NutsHWC · Special | 10/09/2024SE |
| K230242 | OsteoCentric Dental Implant SystemDZE · Traditional | 10/05/2023SE |
| K230226 | Integrity-SI® Fusion SystemOUR · Special | 09/21/2023SE |
| K230595 | OsteoCentric ACL Fixation SystemHWC · Traditional | 06/29/2023SE |
| K230764 | OsteoCentric Integrated Hip Fastener SystemJDO · Special | 04/18/2023SE |
| K222512 | Integrity-SI Fusion SystemOUR · Special | 09/12/2022SE |
| K221332 | OsteoCentric Spine MIS Pedicle Fastener SystemNKB · Traditional | 07/28/2022SE |
| K211290 | Cannulated Fasteners and NutsHWC · Special | 08/03/2021SE |
Questions and answers
When was The OsteoCentric Bone Plate and Screw System cleared by the FDA?
The OsteoCentric Bone Plate and Screw System (K250494) received a 510(k) decision of Substantially Equivalent on March 18, 2025, 26 days after the submission was received.
What is the product code of K250494?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.