Identity
- Trade Name
- Phantom Hindfoot TTC/TC Nail System FDA UDI
- Generic Name
- Bone nail driver FDA UDI
- Device Name
- Phantom Screw Driver Attachment, Cannulated, 3/16" Sq. Connection, TX-30 x 85mm FDA UDI
- Model / Reference
- P31-190-TX30-09 FDA UDI
- Description
- Phantom Screw Driver Attachment, Cannulated, 3/16" Sq. Connection, TX-30 x 85mm FDA UDI
Identifiers
- Catalog Number
- P31-190-TX30-09 FDA UDI
- Primary DI / UDI-DI
- 00889795098146 FDA UDI
- 510(k) Number
- K201227 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Bone nail driver 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
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Bone nail driver
Phantom Hindfoot TTC/TC Nail System by Paragon 28 — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Bone nail driver.
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Cleared under the same submission
K201227 also covers:
- Phantom Hindfoot TTC/TC Nail System — Paragon 28
- Phantom Hindfoot TTC/TC Nail System — Paragon 28
- Phantom Hindfoot TTC/TC Nail System — Paragon 28
- Phantom Hindfoot TTC/TC Nail System — Paragon 28
- Phantom Hindfoot TTC/TC Nail System — Paragon 28
- Phantom Hindfoot TTC/TC Nail System — Paragon 28
- Phantom Hindfoot TTC/TC Nail System — Paragon 28
- Phantom Hindfoot TTC/TC Nail System — Paragon 28
- Phantom Hindfoot TTC/TC Nail System — Paragon 28
- Phantom Hindfoot TTC/TC Nail System — Paragon 28
- Phantom Hindfoot TTC/TC Nail System — Paragon 28
- Phantom Hindfoot TTC/TC 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 57a02249-2536-4931-b2d8-e8bdd723e3f9 35 fields · synced May 29, 2026