Identity
- Trade Name
- Phantom® Fibula Nail System FDA UDI
- Generic Name
- Fluted surgical drill bit, single-use FDA UDI
- Device Name
- 3.2mm R3ACT Drill Bit, 14mm Calibrated, AO Quick Connect FDA UDI
- Model / Reference
- P36-910-3214 FDA UDI
- Description
- 3.2mm R3ACT Drill Bit, 14mm Calibrated, AO Quick Connect FDA UDI
Identifiers
- Catalog Number
- P36-910-3214 FDA UDI
- Primary DI / UDI-DI
- 00889795137074 FDA UDI
- 510(k) Number
- K234128 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Fluted surgical drill bit, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3020 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Fluted surgical drill bit, single-use
Phantom® Fibula Nail System by Paragon 28 — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K234128 also covers:
- Phantom® Fibula Nail System — Paragon 28
- Phantom® Fibula Nail System — Paragon 28
- Phantom® Fibula Nail System — Paragon 28
- Phantom® Fibula Nail System — Paragon 28
- Phantom® Fibula Nail System — Paragon 28
- Phantom® Fibula Nail System — Paragon 28
- Phantom® Fibula Nail System — Paragon 28
- Phantom® Fibula Nail System — Paragon 28
- Phantom® Fibula Nail System — Paragon 28
- Phantom® Fibula Nail System — Paragon 28
- Phantom® Fibula Nail System — Paragon 28
- Phantom® Fibula Nail System — Paragon 28
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Paragon 28
Sources (1)
- FDA UDI 07016df7-1b41-43c1-92fb-9c60159b205e 35 fields · synced Jun 8, 2026