Identity
- Trade Name
- ALPHALOK Plating System FDA UDI
- Generic Name
- Fluted surgical drill bit, single-use FDA UDI
- Device Name
- ANKLE FX Drill, Hook Plate, Cannulated 2.1mm FDA UDI
- Model / Reference
- TZ-DRILL-21 FDA UDI
- Description
- ANKLE FX Drill, Hook Plate, Cannulated 2.1mm FDA UDI
Identifiers
- Catalog Number
- TZ-DRILL-21 FDA UDI
- Primary DI / UDI-DI
- 00841731134066 FDA UDI
- 510(k) Number
- K230204 FDA UDI
- FDA Product Code
- HTW FDA UDI
- GMDN Term
- Fluted surgical drill bit, single-use 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: Fluted surgical drill bit, single-use
ALPHALOK Plating System by Vilex, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K230204 also covers:
- ALPHALOK Plating System — Vilex, Inc.
- ALPHALOK Plating System — Vilex, Inc.
- ALPHALOK Plating System — Vilex, Inc.
- ALPHALOK Plating System — Vilex, Inc.
- ALPHALOK Plating System — Vilex, Inc.
- ALPHALOK Plating System — Vilex, Inc.
- ALPHALOK Plating System — Vilex, Inc.
- ALPHALOK Plating System — Vilex, Inc.
- ALPHALOK Plating System — Vilex, Inc.
- ALPHALOK Plating System — Vilex, Inc.
- ALPHALOK Plating System — Vilex, Inc.
- ALPHALOK Plating System — 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 baea4b52-8454-4680-8176-ff5abdf309f6 35 fields · synced May 30, 2026