FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
TrueLok Elevate
K Number: K242861
·
Decision Dec 3, 2024
Classifications
1
FEI Numbers
249
Registration Numbers
249
Same Product Code
403
Applicant Total
38
Review Days
74
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Basic Information
- Device Name
- TrueLok Elevate
- K Number
- K242861
- 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
- September 20, 2024
- Decision Date
- December 3, 2024
- 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 Orthofix Srl
| K Number | Device Name | ||
|---|---|---|---|
| K260146 | FITBONE® TRANSPORT AND LENGTHENING SYSTEM | May 19, 2026 | Substantially Equivalent |
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| K250112 | FitboneTM Trochanteric | Apr 10, 2025 | Substantially Equivalent |
| K242270 | OrthoNext Platform System | Dec 19, 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 |
| K210157 | SOLE Medial Column Fusion Plate | Apr 20, 2021 | Substantially Equivalent |