Phantom Fibula Nail System
FDA 510(k) clearance K234128 · decided 2024-08-22
Clearance details
- K-number
- K234128
- Device name
- Phantom Fibula Nail System
- Applicant
- Paragon 28, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-12-28
- Decision date
- 2024-08-22
- Days to decision
- 238 days
- Clearance type
- Traditional
- Product code
- HSB
- Device class
- 2
- Regulation number
- 888.3020
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Englewood, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S recall (Z-0871-2026) | Paragon 28, Inc. | 2025-12-02 |