Identity
- Trade Name
- Elite Expandable Interbody Fusion System FDA UDI
- Generic Name
- Metallic spinal interbody fusion cage FDA UDI
- Device Name
- Asm, 10 mm Fork FDA UDI
- Model / Reference
- 102-26-01 FDA UDI
- Description
- Asm, 10 mm Fork FDA UDI
Identifiers
- Catalog Number
- 100-1249 FDA UDI
- Primary DI / UDI-DI
- M7401001249 FDA UDI
- 510(k) Number
- K162879 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Metallic spinal interbody fusion cage 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
Yes
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 interbody fusion cage
Elite Expandable Interbody Fusion System by Spineology Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Metallic spinal interbody fusion cage.
- KODIAK CERVICAL IMPLANT, 14x16mm, 10mmx6° — MET 1 TECHNOLOGIES, LLC · Class II
- Peridot-PT Anterior Cervical Intervertebral body fusion system — GBS Commonwealth Co., Ltd. · Class II
- CoRoent — Nuvasive, Inc. · Class II
- Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II
- MectaLIF 3D — Medacta International · Class II
- PILLAR TL — Orthofix US LLC · Class II
- Solar™ Interbody Fusion System — Degen Medical · Class II
- Peridot-TD Anterior Cervical Intervertebral body fusion system — GBS Commonwealth 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 f01ef24d-2841-4ca0-98f4-548a4fe52a39 37 fields · synced May 30, 2026