FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Extremity Medical External Fixation System
K Number: K241563
·
Decision Feb 21, 2025
Classifications
1
FEI Numbers
249
Registration Numbers
249
Same Product Code
403
Applicant Total
28
Review Days
266
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Basic Information
- Device Name
- Extremity Medical External Fixation System
- K Number
- K241563
- 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
- May 31, 2024
- Decision Date
- February 21, 2025
- 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 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 |
| 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 |
| K180808 | Omni Foot Plating System | May 22, 2018 | Substantially Equivalent |
| K172260 | Omni Foot Plating System | Nov 6, 2017 | Substantially Equivalent |