FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
FitboneTM Trochanteric
K Number: K250112
·
Decision Apr 10, 2025
Classifications
1
FEI Numbers
302
Registration Numbers
302
Same Product Code
528
Applicant Total
38
Review Days
84
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Basic Information
- Device Name
- FitboneTM Trochanteric
- K Number
- K250112
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3020
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Orthofix Srl
- Date Received
- January 16, 2025
- Decision Date
- April 10, 2025
- Product Code
- HSB
- 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 |
|---|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | 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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| K232169 | FITBONE® Transport and Lengthening System | Mar 22, 2024 | Substantially Equivalent |
| K213572 | JuniOrtho Plating System | Jan 18, 2022 | Substantially Equivalent |
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