Identity
- Trade Name
- Aurora Spine FDA UDI
- Generic Name
- Polymeric spinal fusion cage, sterile FDA UDI
- Device Name
- ECHO, TRIAL-P, 22mm, 8mm, 14mm FDA UDI
- Model / Reference
- ECHO FDA UDI
- Description
- ECHO, TRIAL-P, 22mm, 8mm, 14mm FDA UDI
Identifiers
- Catalog Number
- 108-32208-014 FDA UDI
- Primary DI / UDI-DI
- B521108322080140 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
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Angle — 0 degree FDA UDIHeight — 14 Millimeter FDA UDIWidth — 8 Millimeter FDA UDILength — 22 Millimeter FDA UDI
Category: Polymeric spinal fusion cage, sterile
Aurora Spine is a non-surgical, spinal fusion device used to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks (DDD). This sterile device is intended for implantation between the bones or bone grafts of the spine.
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 29086974-649b-420a-bd3e-42a45bdf2f55 37 fields · synced Jul 18, 2026