Identity
- Trade Name
- TiNano FDA UDI
- Generic Name
- Polymeric spinal fusion cage, sterile FDA UDI
- Device Name
- DISCOVERY Cervical Interbody Fusion System, 12mm x 14mm x 5 degrees x 11mm FDA UDI
- Model / Reference
- DISCOVERY FDA UDI
- Description
- DISCOVERY Cervical Interbody Fusion System, 12mm x 14mm x 5 degrees x 11mm FDA UDI
Identifiers
- Catalog Number
- 105-000-511 FDA UDI
- Primary DI / UDI-DI
- B5211050005110 FDA UDI
- 510(k) Number
- K111484 FDA UDI
- FDA Product Code
- ODP FDA UDI
- GMDN Term
- Polymeric spinal fusion cage, sterile 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
No
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
Dimensions & Sizes
- Size
- Height — 11 Millimeter FDA UDIAngle — 5 degree FDA UDIWidth — 14 Millimeter FDA UDILength — 12 Millimeter FDA UDI
Category: Polymeric spinal fusion cage, sterile
TiNano by Aurora Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polymeric spinal fusion cage, sterile.
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- TALOS®-C — MEDITECH SPINE, LLC · Class II
- Avenue T — Ldr Spine USA · Class II
- EVOS Lumbar Interbody System — CUTTING EDGE SPINE · Class II
- VertebraLINK MI — LINKSPINE, INC. · Class I
- TALOS® IBF — MEDITECH SPINE, LLC · Class II
Cleared under the same submission
K111484 also covers:
- Aurora Spine — AURORA SPINE, INC.
- Aurora Spine — AURORA SPINE, INC.
- Aurora Spine — AURORA SPINE, INC.
- Aurora Spine — AURORA SPINE, INC.
- Aurora Spine — AURORA SPINE, INC.
- Aurora Spine — AURORA SPINE, INC.
- Aurora Spine — AURORA SPINE, INC.
- Aurora Spine — AURORA SPINE, INC.
- Aurora Spine — AURORA SPINE, INC.
- Aurora Spine — AURORA SPINE, INC.
- Aurora Spine — AURORA SPINE, INC.
- Aurora Spine — AURORA SPINE, INC.
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
- Aurora Spine, Inc.
Sources (1)
- FDA UDI a92d3ebc-d05f-48f5-b4fa-82d592a3ca61 37 fields · synced Jun 1, 2026