Identity
- Trade Name
- TRUELOK SYSTEM FDA UDI
- Generic Name
- Orthopaedic bone wire FDA UDI
- Device Name
- TL PLUS BAYONET WIRE WITH OLIVE L300MM D1.5MM FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- TL PLUS BAYONET WIRE WITH OLIVE L300MM D1.5MM FDA UDI
Identifiers
- Catalog Number
- 54-1217 FDA UDI
- Primary DI / UDI-DI
- 18056099649360 FDA UDI
- 510(k) Number
- K172698 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Orthopaedic bone wire FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 1.5 Millimeter FDA UDILength — 300 Millimeter FDA UDI
Category: Orthopaedic bone wire
Truelok System by Orthofix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic bone wire.
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Cleared under the same submission
K172698 also covers:
- FRAGMENT FIXATION SYSTEM — Orthofix, Inc.
- FRAGMENT FIXATION SYSTEM — Orthofix, Inc.
- G-Beam Fusion Beaming System — Orthofix, Inc.
- G-Beam Fusion Beaming System — Orthofix, Inc.
- G-Beam Fusion Beaming System — Orthofix, Inc.
- G-Beam Fusion Beaming System — Orthofix, Inc.
- G-Beam Fusion Beaming System — Orthofix, Inc.
- G-Beam Fusion Beaming System — Orthofix, Inc.
- G-Beam Fusion Beaming System — Orthofix, Inc.
- G-Beam Fusion Beaming System — Orthofix, Inc.
- G-Beam Fusion Beaming System — Orthofix, Inc.
- G-Beam Fusion Beaming System — Orthofix, 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 II | Pending data |
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Manufacturer
- Manufacturer
- Orthofix, Inc.
Sources (1)
- FDA UDI c5cbe0ce-9f55-4acc-b43b-19252baa1286 37 fields · synced Jun 6, 2026