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, 42 X 30 X 8°, 15mm, PC (STERILE) FDA UDI
- Model / Reference
- X080-423015-08PC-STRX FDA UDI
- Description
- IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 8°, 15mm, PC (STERILE) FDA UDI
Identifiers
- Primary DI / UDI-DI
- M697X08042301508PCSTRX1 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
- Height — 15 Millimeter FDA UDIAngle — 8 degree FDA UDIWidth — 42 Millimeter FDA UDILength — 30 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
Similar devices
Also classified as Metal-polymer composite spinal interbody fusion cage.
- Battalion Universal Spinal Spacer System — ALPHATEC SPINE, INC. · Class II
- Tyber Medical — Tyber Medical · Class II
- Reef TA — SeaSpine Orthopedics Corporation · Class II
- ROI-C — Ldr Spine USA · Class II
- LUCENT XP ARC — SPINAL ELEMENTS, INC. · Class II
- Shoreline ACS — SeaSpine Orthopedics Corporation · Class II
- MIDLINE II-Ti — Centinel Spine, LLC · Class II
- Latitude-C Cervical Interbody Spacer System — Degen Medical · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Xtant Medical Holdings, Inc.
Sources (1)
- FDA UDI 6f6e2e22-aebd-4856-839b-8e2b2017abe1 35 fields · synced Jun 8, 2026