Identity
- Trade Name
- X-CORE FDA UDI
- Generic Name
- Vertebral body prosthesis FDA UDI
- Device Name
- X-CORE Mini Core, Ø12mm 25-40mm FDA UDI
- Model / Reference
- 5962253P2 FDA UDI
- Description
- X-CORE Mini Core, Ø12mm 25-40mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00887517678027 FDA UDI
- 510(k) Number
- K193506 FDA UDI
- FDA Product Code
- MQP FDA UDIPLR FDA UDI
- GMDN Term
- Vertebral body prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Radiation Sterilization FDA UDI
Category: Vertebral body prosthesis
X-Core by Nuvasive, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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
- Nuvasive, Inc.
Sources (1)
- FDA UDI c8b75ece-4273-47c9-ae99-03b9afb6c2c1 35 fields · synced Jun 8, 2026