Identity
- Trade Name
- Xsert Lumbar Expandable Interbody System FDA UDI
- Generic Name
- Metallic spinal interbody fusion cage FDA UDI
- Device Name
- 7mm-10mm x 10mm x 32mm PLIF ASSY (Sterile) FDA UDI
- Model / Reference
- X092-071032-STR FDA UDI
- Description
- 7mm-10mm x 10mm x 32mm PLIF ASSY (Sterile) FDA UDI
Identifiers
- Primary DI / UDI-DI
- M697X092071032STR1 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
Yes
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
Radiation Sterilization FDA UDI
Dimensions & Sizes
- Size
- Width — 10 Millimeter FDA UDILength — 32 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 7a6d319d-9c1b-403b-b551-fe9b98468118 36 fields · synced May 31, 2026