Identity
- Trade Name
- FUZE FDA UDI
- Generic Name
- Tibia nail, non-sterile FDA UDI
- Device Name
- Screw, FUZE 5.0x030mm_Ti Hexalobe Teal FDA UDI
- Model / Reference
- FTZ50-30TH FDA UDI
- Description
- Screw, FUZE 5.0x030mm_Ti Hexalobe Teal FDA UDI
Identifiers
- Catalog Number
- FTZ50-30TH FDA UDI
- Primary DI / UDI-DI
- 00841731120267 FDA UDI
- 510(k) Number
- K102413 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Tibia nail, non-sterile 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
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: Tibia nail, non-sterile
Fuze by Vilex, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tibia nail, non-sterile.
- AIM™DYNAMIC TIBIAL NAIL — Biomet Orthopedics, Inc. · Class II
- RENOVOLIFE LLC — Renovo Life, LLC · Class II
- AIM™DYNAMIC TIBIAL NAIL — Biomet Orthopedics, Inc. · Class II
- Dyna Locking IM Nail — CG MedTech Co., Ltd. · Class II
- AIM™DYNAMIC TIBIAL NAIL — Biomet Orthopedics, Inc. · Class II
- Stainless Steel Tibial Nailing System — Orthofix, Inc. · Class II
- Stainless Steel Tibial Nailing System — Orthofix, Inc. · Class II
- AIM™DYNAMIC TIBIAL NAIL — Biomet Orthopedics, Inc. · Class II
Cleared under the same submission
K102413 also covers:
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
- Vilex, Inc.
Sources (1)
- FDA UDI 836c26f4-d7ad-4251-a6ec-165fb459531d 35 fields · synced Jun 8, 2026