Identity
- Trade Name
- Irix-A Lumbar Integrated Fusion System FDA UDI
- Generic Name
- Metal-polymer composite spinal interbody fusion cage FDA UDI
- Device Name
- IRIX-A INTEGRATED SPACER ASSY, 33 X 26 X 16°, 17mm, PC (STERILE) FDA UDI
- Model / Reference
- X080-332617-16PC-STR FDA UDI
- Description
- IRIX-A INTEGRATED SPACER ASSY, 33 X 26 X 16°, 17mm, PC (STERILE) FDA UDI
Identifiers
- Primary DI / UDI-DI
- M697X08033261716PCSTR1 FDA UDI
- FDA Product Code
- OVD FDA UDI
- GMDN Term
- Metal-polymer composite spinal interbody fusion cage FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 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
No
FDA UDI
Radiation Sterilization FDA UDI
Dimensions & Sizes
- Size
- Width — 33 Millimeter FDA UDI
Category: Metal-polymer composite spinal interbody fusion cage
Irix-A Lumbar Integrated Fusion System by Xtant Medical Holdings, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 f1f63e98-fa8c-4f96-869f-10c7bb47eeb9 35 fields · synced Jun 8, 2026