Identity
- Trade Name
- Aurora Spine FDA UDI
- Generic Name
- Polymeric spinal fusion cage, sterile FDA UDI
- Device Name
- AFFINITY Lumbar Interbody Fusion System, 24mm x 30mm x 8 degrees x 12mm, UNCOATED FDA UDI
- Model / Reference
- AFFINITY FDA UDI
- Description
- AFFINITY Lumbar Interbody Fusion System, 24mm x 30mm x 8 degrees x 12mm, UNCOATED FDA UDI
Identifiers
- Catalog Number
- 106-02430-0812-UC FDA UDI
- Primary DI / UDI-DI
- B521106024300812UC0 FDA UDI
- 510(k) Number
- K133967 FDA UDI
- FDA Product Code
- MAX 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 — 12 Millimeter FDA UDIAngle — 8 degree FDA UDIWidth — 30 Millimeter FDA UDILength — 24 Millimeter FDA UDI
Category: Polymeric spinal fusion cage, sterile
Aurora Spine 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.
- TALOS® IBF — MEDITECH SPINE, LLC · Class II
- ROCCIA — Silony Medical GmbH · Class II
- EVOS Lumbar Interbody System — CUTTING EDGE SPINE · Class II
- 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
K133967 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 59e83717-e48f-4bcd-a9ec-40a910863b4b 37 fields · synced Jun 6, 2026