Identity
- Trade Name
- K-Wires FDA UDI
- Generic Name
- Orthopaedic intraoperative positioning pin, single-use FDA UDI
- Device Name
- K-Wire 0.9mm, 120mm FDA UDI
- Model / Reference
- WIRE-0.9/120 FDA UDI
- Description
- K-Wire 0.9mm, 120mm FDA UDI
Identifiers
- Catalog Number
- WIRE-0.9/120 FDA UDI
- Primary DI / UDI-DI
- 00842188123863 FDA UDI
- 510(k) Number
- K010545 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic intraoperative positioning pin, 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic intraoperative positioning pin, single-use
K-Wires by Trimed, INC. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K010545 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Trimed, INC.
Sources (1)
- FDA UDI 3a37d5fd-5c0b-4178-b5a4-44b18810ec34 36 fields · synced Jun 7, 2026