Identity
- Trade Name
- Phantom® Fibula Nail System FDA UDI
- Generic Name
- Arthrodesis intramedullary nail, non-distracting FDA UDI
- Device Name
- 4.0mm x 270mm, Right, Ti, Fibula Nail, Sterile FDA UDI
- Model / Reference
- P36-140-270R-S FDA UDI
- Description
- 4.0mm x 270mm, Right, Ti, Fibula Nail, Sterile FDA UDI
Identifiers
- Catalog Number
- P36-140-270R-S FDA UDI
- Primary DI / UDI-DI
- 00889795133809 FDA UDI
- 510(k) Number
- K234128 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Arthrodesis intramedullary nail, non-distracting 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
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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: Arthrodesis intramedullary nail, non-distracting
Phantom® Fibula Nail System by Paragon 28 — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Arthrodesis intramedullary nail, non-distracting.
- AUTOBAHN — GLOBUS MEDICAL, INC. · Class II
- AUTOBAHN — GLOBUS MEDICAL, INC. · Class II
- Reconstruction nail; long, 12×320 mm, 135°, left, cannulated — MEDIN, a.s. · Class IIb
- ZİMED MEDİKAL SANAYİ VE TİCARET LİMİTED ŞİRKETİ — Zimed Medikal Sanayi ve Ticaret Limited Şirketi · Class IIb
- INTREX — Bonetech Medisys Pvt. Ltd. · Class IIb
- Locking Screw — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- Ankle Compression Nailing System — Orthofix, Inc. · Class II
- Femoral Nail — WUHAN MINDRAY SCIENTIFIC CO., LTD. · Class IIb
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 |
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Manufacturer
- Manufacturer
- Paragon 28
Sources (1)
- FDA UDI 31d1fb55-8eb1-4de6-8133-519cb2fea97b 35 fields · synced Jun 6, 2026