Identity
- Trade Name
- Duo Ti Expandable Interbody Fusion System FDA UDI
- Generic Name
- Surgical implant/trial-implant/sizer holder, reusable FDA UDI
- Device Name
- Wide Duo Trial, 8 degree FDA UDI
- Model / Reference
- 102-42-02 FDA UDI
- Description
- Wide Duo Trial, 8 degree FDA UDI
Identifiers
- Catalog Number
- 100-1279 FDA UDI
- Primary DI / UDI-DI
- M7401001279 FDA UDI
- 510(k) Number
- K210155 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Surgical implant/trial-implant/sizer holder, reusable 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
- Angle — 8 degree FDA UDI
Category: Surgical implant/trial-implant/sizer holder, reusable
Duo Ti Expandable Interbody Fusion System by Spineology Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical implant/trial-implant/sizer holder, reusable.
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- ARx — Life Spine, Inc. · Class II
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- JULIET INSTRUMENTATION — Spineart · Class II
- JOURNEY II XR — Smith & Nephew, Inc. · Class II
- TALOS® (HA) IBF — MEDITECH SPINE, LLC · Class II
- BENCOX THR System — Corentec Co., Ltd · Class II
Cleared under the same submission
K210155 also covers:
- Duo Ti Expandable Interbody Fusion System — SPINEOLOGY INC.
- Duo Ti Expandable Interbody Fusion System — SPINEOLOGY INC.
- Duo Ti Expandable Interbody Fusion System — SPINEOLOGY INC.
- Duo Ti Expandable Interbody Fusion System — SPINEOLOGY INC.
- Duo Ti Expandable Interbody Fusion System — SPINEOLOGY INC.
- Duo Ti Expandable Interbody Fusion System — SPINEOLOGY INC.
- Duo Ti Expandable Interbody Fusion System — SPINEOLOGY INC.
- Duo Ti Expandable Interbody Fusion System — SPINEOLOGY INC.
- Duo Ti Expandable Interbody Fusion System — SPINEOLOGY INC.
- Duo Ti Expandable Interbody Fusion System — SPINEOLOGY INC.
- Duo Ti Expandable Interbody Fusion System — SPINEOLOGY INC.
- Duo Ti Expandable Interbody Fusion System — 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 0b9bf926-175d-4882-91f0-acdbef00923a 37 fields · synced Jun 8, 2026