Identity
- Trade Name
- Phantom® Fibula Nail System FDA UDI
- Generic Name
- Orthopaedic implantation sleeve, reusable FDA UDI
- Device Name
- Curved K-Wire Reduction Sleeve, Non-Targeting FDA UDI
- Model / Reference
- P36-955-2002 FDA UDI
- Description
- Curved K-Wire Reduction Sleeve, Non-Targeting FDA UDI
Identifiers
- Catalog Number
- P36-955-2002 FDA UDI
- Primary DI / UDI-DI
- 00889795134790 FDA UDI
- 510(k) Number
- K234128 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthopaedic implantation sleeve, reusable
Phantom® Fibula 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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- DRILL SLEEVE — Biomet Orthopedics, Inc. · Class I
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 a983b0dc-c6f4-47eb-a3e0-2c6315ca1a18 35 fields · synced Jun 8, 2026