FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Omni Foot Plating System
K Number: K180808
·
Decision May 22, 2018
Classifications
1
FEI Numbers
519
Registration Numbers
519
Same Product Code
1313
Applicant Total
28
Review Days
55
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
- Omni Foot Plating System
- K Number
- K180808
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Extremity Medical, LLC
- Date Received
- March 28, 2018
- Decision Date
- May 22, 2018
- 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 Extremity Medical, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K250536 | MetaFore Small Screw System | Oct 8, 2025 | Substantially Equivalent |
| K251128 | Extremity Medical External Fixation System | May 7, 2025 | Substantially Equivalent |
| K241563 | Extremity Medical External Fixation System | Feb 21, 2025 | Substantially Equivalent |
| K212297 | Omni Foot and Ankle Plating System | Aug 20, 2021 | Substantially Equivalent |
| K211261 | Axis Charcot Fixation System | May 28, 2021 | Substantially Equivalent |
| K201556 | Intraosseous Fixation System | Jul 8, 2020 | Substantially Equivalent |
| K191525 | KinematX Total Wrist Arthroplasty System | Mar 4, 2020 | Substantially Equivalent |
| K192592 | Axis Plating System | Nov 21, 2019 | Substantially Equivalent |
| K181067 | AlignX Ankle Fusion System | May 23, 2018 | Substantially Equivalent |
| K172260 | Omni Foot Plating System | Nov 6, 2017 | Substantially Equivalent |