Eminent Foot Plate System
FDA 510(k) K143365 · Eminent Spine
510(k) numberK143365
Submission
- Device name
- Eminent Foot Plate System
- Applicant
- Eminent Spine
Georgetown, TX, US - Received
- November 24, 2014
- Decision date
- March 30, 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 |
|---|---|---|
| K250894 | Eminent Spine Posterior SI SystemOUR · Traditional | 10/07/2025SE |
| K241663 | Eminent Spine 3D Titanium Pedicle Screw SystemNKB · Traditional | 04/28/2025SE |
| K242069 | Eminent Spine Scoliosis Deformity Pedicle Screw SystemNKB · Special | 09/03/2024SE |
| K240505 | Eminent Spine SI Screw SystemOUR · Traditional | 06/04/2024SE |
| K230219 | Eminent Spine 3D Lumbar Interbody Fusion SystemsMAX · Traditional | 05/16/2023SE |
| K212701 | Eminent Spine 3D Cervical Interbody Fusion SystemODP · Traditional | 02/06/2023SE |
| K221936 | Standalone ALIF Interbody Fusion SystemOVD · Traditional | 10/17/2022SE |
| K212853 | Cervical Stand-Alone SystemOVE · Traditional | 11/05/2021SE |
| K201979 | Cervical Plate SystemKWQ · Traditional | 08/25/2020SE |
| K133194 | Diamond Rattlesnake SystemKWQ · Traditional | 06/26/2014SE |
Questions and answers
When was Eminent Foot Plate System cleared by the FDA?
Eminent Foot Plate System (K143365) received a 510(k) decision of Substantially Equivalent on March 30, 2015, 126 days after the submission was received.
What is the product code of K143365?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.