Identity
- Trade Name
- Pro-X1 FDA UDI
- Generic Name
- Orthopaedic intraoperative positioning pin, single-use FDA UDI
- Device Name
- Ø3.2mm x 390mm Femoral Head K-wire FDA UDI
- Model / Reference
- XBT032001 FDA UDI
- Description
- Ø3.2mm x 390mm Femoral Head K-wire FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05397283000304 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Orthopaedic intraoperative positioning pin, single-use 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
No
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
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Length — 390 Millimeter FDA UDI
Category: Orthopaedic intraoperative positioning pin, single-use
Pro-X1 by X-Bolt Orthopedics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- X-Bolt Orthopedics
Sources (1)
- FDA UDI b255634d-8aea-4c2d-99f2-964fc9d6e5d8 34 fields · synced May 31, 2026