FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
SOLE Medial Column Fusion Plate
K Number: K210157
·
Decision Apr 20, 2021
Classifications
1
FEI Numbers
519
Registration Numbers
519
Same Product Code
1313
Applicant Total
38
Review Days
89
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SOLE Medial Column Fusion Plate
- K Number
- K210157
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Orthofix Srl
- Date Received
- January 21, 2021
- Decision Date
- April 20, 2021
- Product Code
- HRS
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HRS), ordered by most recent decision date.
I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. Olecranonplate with Angular Stability; I.T.S. Straight Plate with Angular Stability; I.T.S. Screw System; I.T.S. PRS Sacral Rod System; I.T.S. Fibula Plate PROlock with Angular Stability; I.T.S. Distal Humeral Plates with Angular Stability; I.T.S. LRS (L
FDA 510(k)
FDA Class 2
·Orthopedic
Exalta Proximal Tibia Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
APTUS Clavicle System 2.8
FDA 510(k)
FDA Class 2
·Orthopedic
Pectus Blu System
FDA 510(k)
FDA Class 2
·Orthopedic
Xpert PFP
FDA 510(k)
FDA Class 2
·Orthopedic
Avanti Distal Elbow ORIF System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Orthofix Srl
| K Number | Device Name | ||
|---|---|---|---|
| K260146 | FITBONE® TRANSPORT AND LENGTHENING SYSTEM | May 19, 2026 | Substantially Equivalent |
| K253991 | Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA | May 8, 2026 | Substantially Equivalent |
| K250112 | FitboneTM Trochanteric | Apr 10, 2025 | Substantially Equivalent |
| K242270 | OrthoNext Platform System | Dec 19, 2024 | Substantially Equivalent |
| K242861 | TrueLok Elevate | Dec 3, 2024 | Substantially Equivalent |
| K233867 | Fitbone Trochanteric | Jun 18, 2024 | Substantially Equivalent |
| K232648 | RODEO Telescopic Nail | May 3, 2024 | Substantially Equivalent |
| K232169 | FITBONE® Transport and Lengthening System | Mar 22, 2024 | Substantially Equivalent |
| K213572 | JuniOrtho Plating System | Jan 18, 2022 | Substantially Equivalent |
| K212044 | TrueLok Evo | Nov 5, 2021 | Substantially Equivalent |