FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Omni Foot and Ankle Plating System
K Number: K212297
·
Decision Aug 20, 2021
Classifications
1
FEI Numbers
519
Registration Numbers
519
Same Product Code
1313
Applicant Total
28
Review Days
29
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Basic Information
- Device Name
- Omni Foot and Ankle Plating System
- K Number
- K212297
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Extremity Medical, LLC
- Date Received
- July 22, 2021
- Decision Date
- August 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
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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
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|---|---|---|---|
| K250536 | MetaFore Small Screw System | Oct 8, 2025 | Substantially Equivalent |
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| K241563 | Extremity Medical External Fixation System | Feb 21, 2025 | 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 |
| K180808 | Omni Foot Plating System | May 22, 2018 | Substantially Equivalent |
| K172260 | Omni Foot Plating System | Nov 6, 2017 | Substantially Equivalent |