Identity
- Trade Name
- FortiCore FDA UDI
- Generic Name
- Metal-polymer composite spinal interbody fusion cage FDA UDI
- Device Name
- FortiCore PLIF Trial 14x10x28, (6°) FDA UDI
- Model / Reference
- 10494-2814 FDA UDI
- Description
- FortiCore PLIF Trial 14x10x28, (6°) FDA UDI
Identifiers
- Catalog Number
- 10494-2814 FDA UDI
- Primary DI / UDI-DI
- 00814216023940 FDA UDI
- FDA Product Code
- MAX 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
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
- Height — 14 Millimeter FDA UDILength — 28 Millimeter FDA UDIWidth — 10 Millimeter FDA UDI
Category: Metal-polymer composite spinal interbody fusion cage
FortiCore by Nanovis Spine, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Metal-polymer composite spinal interbody fusion cage.
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- Shoreline ACS — SeaSpine Orthopedics Corporation · Class II
- MIDLINE II-Ti — Centinel Spine, LLC · 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 |
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Manufacturer
- Manufacturer
- Nanovis Spine, Llc
Sources (1)
- FDA UDI 2c878acc-c7a6-414f-ab70-c5e54b7041e0 36 fields · synced Jun 1, 2026