FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ONX Large External Fixation System
K Number: K213905
·
Decision Aug 25, 2022
Classifications
1
FEI Numbers
249
Registration Numbers
249
Same Product Code
403
Applicant Total
5
Review Days
254
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Basic Information
- Device Name
- ONX Large External Fixation System
- K Number
- K213905
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Orthonovis, Inc.
- Date Received
- December 14, 2021
- Decision Date
- August 25, 2022
- Product Code
- KTT
- 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 |
|---|---|---|---|
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | FDA class 2 | Orthopedic |
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Other Clearances by Orthonovis, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252758 | Cannulated Screw and Kirschner (K wire) System | Oct 2, 2025 | Substantially Equivalent |
| K250498 | BPS Wrist Fracture System | Mar 17, 2025 | Substantially Equivalent |
| K250055 | BPS - Bone Fragment Fixation Plates, Screws and Washers | Feb 6, 2025 | Substantially Equivalent |
| K242343 | BPS Wrist Fracture System | Oct 4, 2024 | Substantially Equivalent |