FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Phantom® Hindfoot TTC/TC Nail System
K Number: K201227
·
Decision Jul 17, 2020
Classifications
1
FEI Numbers
302
Registration Numbers
302
Same Product Code
528
Applicant Total
50
Review Days
72
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Basic Information
- Device Name
- Phantom® Hindfoot TTC/TC Nail System
- K Number
- K201227
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3020
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Paragon 28, Inc.
- Date Received
- May 6, 2020
- Decision Date
- July 17, 2020
- 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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| K Number | Device Name | ||
|---|---|---|---|
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| K253591 | Phantom® Hindfoot TTC/TC Nail System | Mar 5, 2026 | Substantially Equivalent |
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| K252106 | External Fixation Mini Rail System | Sep 30, 2025 | Substantially Equivalent |
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| K251850 | Phantom® Hindfoot TTC/TC Nail System | Jul 14, 2025 | Substantially Equivalent |
| K250641 | APEX 3D Total Ankle Replacement System | May 1, 2025 | Substantially Equivalent |
| K242452 | Monkey Bars Pin to Bar External Fixation System | Nov 1, 2024 | Substantially Equivalent |
| K234128 | Phantom Fibula Nail System | Aug 22, 2024 | Substantially Equivalent |