Identity
- Trade Name
- X-Guide FDA UDI
- Generic Name
- Surgical planning/navigation-enhancement system FDA UDI
- Device Name
- BONE SCREW - 2.0Ø x 4mm FDA UDI
- Model / Reference
- P007461 FDA UDI
- Description
- BONE SCREW - 2.0Ø x 4mm FDA UDI
Identifiers
- Catalog Number
- P007461 FDA UDI
- Primary DI / UDI-DI
- 00817421020315 FDA UDI
- 510(k) Number
- K150222 FDA UDI
- FDA Product Code
- PLV FDA UDI
- GMDN Term
- Surgical planning/navigation-enhancement system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4120 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: Surgical planning/navigation-enhancement system
X-Guide by X-Nav Technologies, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K150222 also covers:
- X-GUIDE — X-Nav Technologies, LLC
- X-GUIDE — X-Nav Technologies, LLC
- X-GUIDE — X-Nav Technologies, LLC
- X-GUIDE — X-Nav Technologies, LLC
- X-GUIDE — X-Nav Technologies, LLC
- X-GUIDE — X-Nav Technologies, LLC
- X-Guide — X-Nav Technologies, LLC
- X-Guide — X-Nav Technologies, LLC
- X-Guide — X-Nav Technologies, LLC
- X-Guide — X-Nav Technologies, LLC
- X-Guide — X-Nav Technologies, LLC
- X-Guide — X-Nav Technologies, LLC
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-Nav Technologies, LLC
Sources (1)
- FDA UDI c01d750c-8ae0-49b7-bc09-ef8e48690319 36 fields · synced May 30, 2026