Identity
- Trade Name
- Phantom Hindfoot TTC/TC Nail System FDA UDI
- Generic Name
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
- Device Name
- Phantom Nail, Calcaneus Screw, Ø7.2mm x 55mm length, Headless FDA UDI
- Model / Reference
- P31-772-055F FDA UDI
- Description
- Phantom Nail, Calcaneus Screw, Ø7.2mm x 55mm length, Headless FDA UDI
Identifiers
- Catalog Number
- P31-772-055F FDA UDI
- Primary DI / UDI-DI
- 00889795098177 FDA UDI
- 510(k) Number
- K201227 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Orthopaedic bone screw, non-bioabsorbable, non-sterile
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 bone screw, non-bioabsorbable, non-sterile.
- OIC Cannulated Screw System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
- AOS CAPTURED CORTICAL SCREW, FULLY THREADED 6.5mm x 75mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
- APTUS — Medartis Inc. · Class II
- SMOOTH PEG — Biomet Orthopedics, Inc. · Class II
- AOS CANNULATED CANCELLOUS SCREW, FULLY THREADED 7.0mm x 105mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
- QWIX — Newdeal Sas · Class II
- TMS SYSTEM — BIOMET MICROFIXATION, INC · Class II
- Flow-Screw™ — Flow-Fx, LLC · Class II
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 6631d45f-74e8-442c-9598-359662ca99be 35 fields · synced Jun 1, 2026