Identity
- Trade Name
- Phantom Hindfoot TTC/TC Nail System FDA UDI
- Generic Name
- Medullary canal orthopaedic reamer, flexible FDA UDI
- Device Name
- Phantom Hindfoot Reamer, 13.0mm FDA UDI
- Model / Reference
- P31-955-0130 FDA UDI
- Description
- Phantom Hindfoot Reamer, 13.0mm FDA UDI
Identifiers
- Catalog Number
- P31-955-0130 FDA UDI
- Primary DI / UDI-DI
- 00889795055248 FDA UDI
- FDA Product Code
- HTO FDA UDI
- GMDN Term
- Medullary canal orthopaedic reamer, flexible FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
Yes
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: Medullary canal orthopaedic reamer, flexible
Phantom Hindfoot TTC/TC Nail System by Paragon 28 — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Medullary canal orthopaedic reamer, flexible.
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- ARCOS MODULAR REVISION SYSTEM — Biomet Orthopedics, Inc. · Class II
- ARCOS MODULAR REVISION SYSTEM — Biomet Orthopedics, Inc. · Class II
- Arthrex® — Arthrex, Inc. · Class I
- NITINOL MODULAR REAMER HUDSON — Biomet Orthopedics, Inc. · Class I
- Dyna Locking IM Nail — CG MedTech Co., Ltd. · Class I
- OIC Intramedullary Nail System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
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 I | Pending data |
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Manufacturer
- Manufacturer
- Paragon 28
Sources (1)
- FDA UDI 8fbf78da-3e85-44bb-9fe8-7b5653dc1925 34 fields · synced Jun 1, 2026