Identity
- Trade Name
- Vilex Jones Fracture Guidewire FDA UDI
- Generic Name
- Orthopaedic bone wire FDA UDI
- Device Name
- Wire, Guide 1.8x200mm Sgl Trocar FDA UDI
- Model / Reference
- K200-18T FDA UDI
- Description
- Wire, Guide 1.8x200mm Sgl Trocar FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841731123084 FDA UDI
- 510(k) Number
- K191289 FDA UDI
- FDA Product Code
- HXI FDA UDI
- GMDN Term
- Orthopaedic bone wire 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
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
Category: Orthopaedic bone wire
Vilex Jones Fracture Guidewire by Vilex, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone wire.
- mahe medical GmbH — mahe medical gmbh · Class II
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- SMOOTH K-WIRE, DOUBLE END TROCAR POINT — Biomet Orthopedics, Inc. · Class II
- mahe medical GmbH — mahe medical gmbh · Class II
- OIC Variable Angle Small Fragment Locking Plate System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
- THP™ Hip Fracture Plating System — Biomet Orthopedics, Inc. · Class II
- gSource — GSOURCE, LLC. · Class II
Cleared under the same submission
K191289 also covers:
- Vilex Jones Fracture — Vilex, Inc.
- Vilex Jones Fracture — Vilex, Inc.
- Vilex Jones Fracture — Vilex, Inc.
- Vilex Jones Fracture — Vilex, Inc.
- Vilex Jones Fracture — Vilex, Inc.
- Vilex Jones Fracture — Vilex, Inc.
- Vilex Jones Fracture — Vilex, Inc.
- Vilex Jones Fracture — Vilex, Inc.
- Vilex Jones Fracture — Vilex, Inc.
- Vilex Jones Fracture — Vilex, Inc.
- Vilex Jones Fracture — Vilex, Inc.
- Vilex Jones Fracture — Vilex, Inc.
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
- Vilex, Inc.
Sources (1)
- FDA UDI c0502863-b552-4cd3-9e5f-8c1e2a4b69fe 34 fields · synced Jun 8, 2026