Identity
- Trade Name
- Xsert Lumbar Expandable Interbody System FDA UDI
- Generic Name
- Metallic spinal interbody fusion cage FDA UDI
- Device Name
- 12mm-17mm x 10mm x 26mm PLIF ASSY FDA UDI
- Model / Reference
- X092-121026 FDA UDI
- Description
- 12mm-17mm x 10mm x 26mm PLIF ASSY FDA UDI
Identifiers
- Primary DI / UDI-DI
- M697X0921210261 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Metallic spinal interbody fusion cage FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Width — 10 Millimeter FDA UDILength — 26 Millimeter FDA UDI
Xsert Lumbar Expandable Interbody System by Xtant Medical Holdings, Inc. — 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
- Xtant Medical Holdings, Inc.
Sources (1)
- FDA UDI ccd06186-c93d-41a8-96ef-46eb4259e779 36 fields · synced Jun 8, 2026