Identity
- Trade Name
- Elite FDA UDI
- Generic Name
- Metallic spinal fusion cage, non-sterile FDA UDI
- Device Name
- Elite inserter fork, 10mm FDA UDI
- Model / Reference
- 54-89-12 FDA UDI
- Description
- Elite inserter fork, 10mm FDA UDI
Identifiers
- Catalog Number
- 540-9003 FDA UDI
- Primary DI / UDI-DI
- M7405409003 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
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
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Width — 10 Millimeter FDA UDI
Category: Metallic spinal fusion cage, non-sterile
Elite by Spineology Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 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.
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Spineology Inc.
Sources (1)
- FDA UDI 27981541-4eeb-4896-a18d-58f09aad1414 37 fields · synced May 30, 2026