Identity
- Trade Name
- Elite Expandable Interbody Fusion Device FDA UDI
- Generic Name
- Metallic spinal fusion cage, non-sterile FDA UDI
- Device Name
- 10mm Elite Expandable FDA UDI
- Model / Reference
- 10-10-74-44 FDA UDI
- Description
- 10mm Elite Expandable FDA UDI
Identifiers
- Catalog Number
- 541-0016 FDA UDI
- Primary DI / UDI-DI
- M7405410016 FDA UDI
- 510(k) Number
- K162879 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Metallic spinal fusion cage, non-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
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
Yes
FDA UDI
Ethylene Oxide FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Width — 10 Millimeter FDA UDI
Category: Metallic spinal fusion cage, non-sterile
A comprehensive non-sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks.
Similar devices
Also classified as Metallic spinal fusion cage, non-sterile.
- Silverstone Titanium Interbody Fusion System — Altus Spine · Class II
- Silverstone Titanium Interbody Fusion System — Altus Spine · Class II
- TraXis® — ZIMMER SPINE, INC. · Class II
- PLIF Cage — Eisertech, LLC · Class II
- IVA Cage Ti — Dio Medical Co., Ltd. · Class II
- Copperhead — EMINENT SPINE LLC · Class II
- SPIRA™-C Open Matrix Cervical Interbody — CAMBER SPINE TECHNOLOGIES · Class II
- IVA Cage Ti — Dio Medical Co., Ltd. · Class II
Cleared under the same submission
K162879 also covers:
- Elite — SPINEOLOGY INC.
- Elite — SPINEOLOGY INC.
- Elite — SPINEOLOGY INC.
- Elite Expandable Interbody Fusion Device — SPINEOLOGY INC.
- Elite Expandable Interbody Fusion Device — SPINEOLOGY INC.
- Elite Expandable Interbody Fusion Device — SPINEOLOGY INC.
- Elite Expandable Interbody Fusion Device — SPINEOLOGY INC.
- Elite Expandable Interbody Fusion Device — SPINEOLOGY INC.
- Elite Expandable Interbody Fusion Device — SPINEOLOGY INC.
- Elite Expandable Interbody Fusion Device — SPINEOLOGY INC.
- Elite Expandable Interbody Fusion Device — SPINEOLOGY INC.
- Elite Expandable Interbody Fusion Device — SPINEOLOGY 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
- Spineology Inc.
Sources (1)
- FDA UDI 4fc3bc05-0c05-4850-a825-dd3734e40837 37 fields · synced Jul 21, 2026