Identity
- Trade Name
- Opticage Expandable Interbody Implant FDA UDI
- Generic Name
- Metallic spinal interbody fusion cage FDA UDI
- Device Name
- 18mm Width by 45mm Expanded Height, 9mm, by 9mm - 14mm Height Range FDA UDI
- Model / Reference
- 9180-17 FDA UDI
- Description
- 18mm Width by 45mm Expanded Height, 9mm, by 9mm - 14mm Height Range FDA UDI
Identifiers
- Catalog Number
- 9180-17 FDA UDI
- Primary DI / UDI-DI
- 00811954011598 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
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
MR Safe FDA UDI
Opticage Expandable Interbody Implant by Interventional Spine, 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
- Interventional Spine, Inc
Sources (1)
- FDA UDI e0f2068f-74b8-4ff2-9d12-ed0342538b14 36 fields · synced May 31, 2026