Identity
- Trade Name
- Phantom Hindfoot TTC/TC Nail System FDA UDI
- Generic Name
- Orthopaedic implantation sleeve, reusable FDA UDI
- Device Name
- Ghost Outrigger Tibial Screw Guide, 5mm FDA UDI
- Model / Reference
- P31-950-0005 FDA UDI
- Description
- Ghost Outrigger Tibial Screw Guide, 5mm FDA UDI
Identifiers
- Catalog Number
- P31-950-0005 FDA UDI
- Primary DI / UDI-DI
- 00889795055361 FDA UDI
- 510(k) Number
- K201227 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Orthopaedic implantation sleeve, reusable 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: Orthopaedic implantation sleeve, reusable
Phantom Hindfoot TTC/TC Nail System by Paragon 28 — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic implantation sleeve, reusable.
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- Jet-X — Smith & Nephew, Inc. · Class II
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- DRILL SLEEVE — Biomet Orthopedics, Inc. · Class I
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 |
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Manufacturer
- Manufacturer
- Paragon 28
Sources (1)
- FDA UDI 4a77bac1-7692-4e52-9267-46032741f12e 35 fields · synced Jun 1, 2026