Identity
- Trade Name
- ORTHOFIX FDA UDI
- Generic Name
- Orthopaedic guidewire, reusable FDA UDI
- Device Name
- FITBONE KIRSCHNER WIRE L280MM D3MM PACK OF 2 STERILE FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- FITBONE KIRSCHNER WIRE L280MM D3MM PACK OF 2 STERILE FDA UDI
Identifiers
- Catalog Number
- 99-60001039 FDA UDI
- Primary DI / UDI-DI
- 18052469476512 FDA UDI
- 510(k) Number
- K233867 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Orthopaedic guidewire, reusable 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
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 3 Millimeter FDA UDILength — 280 Millimeter FDA UDI
Category: Orthopaedic guidewire, reusable
Orthofix by Orthofix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic guidewire, reusable.
- Orthopaedic Spreader — Synthes GmbH · Class IIa
- LCP — Synthes GmbH · Class IIa
- Guide Wire — I.T.S. GmbH · Class I
- Parallel Wire Guide, for φ2.5 Guide Wire, Adjustable — Double Medical Technology Inc. · Class II
- VERTECEM — Synthes GmbH · Class IIa
- Adapter Fibre Optic Cable Light Cable — Synthes GmbH · Class I
- ZERO-P — Synthes GmbH · Class IIa
- Guidewire, Nitinol, Double Blunt, 1.19 x 610mm — Captiva Spine · Class I
Cleared under the same submission
K233867 also covers:
- ORTHOFIX — Orthofix, Inc.
- ORTHOFIX — Orthofix, Inc.
- ORTHOFIX — Orthofix, Inc.
- ORTHOFIX — Orthofix, Inc.
- ORTHOFIX — Orthofix, Inc.
- ORTHOFIX — Orthofix, Inc.
- ORTHOFIX — Orthofix, Inc.
- ORTHOFIX — Orthofix, Inc.
- ORTHOFIX — Orthofix, Inc.
- ORTHOFIX — Orthofix, Inc.
- ORTHOFIX — Orthofix, Inc.
- ORTHOFIX — 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 ea3924dc-5c8b-449d-a63c-647cfb914040 37 fields · synced Jun 8, 2026