Identity
- Trade Name
- XKnife® FDA UDI
- Generic Name
- Stereotactic radiosurgical invasive head frame FDA UDI
- Device Name
- XKnife 5.0 Installation Kit FDA UDI
- Model / Reference
- XK5 FDA UDI
- Description
- XKnife 5.0 Installation Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10381780252948 FDA UDI
- 510(k) Number
- K100417 FDA UDI
- FDA Product Code
- MUJ FDA UDI
- GMDN Term
- Stereotactic radiosurgical invasive head frame FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
XKnife® by Integra Lifesciences Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Integra Lifesciences Corp.
Sources (1)
- FDA UDI 5178e503-0e37-43ca-a770-601d6d9c820f 36 fields · synced Jun 8, 2026