Identity
- Trade Name
- Idys®-ALIF TiVac FDA UDI
- Generic Name
- Polymeric spinal fusion cage, sterile FDA UDI
- Device Name
- ALIF CAGE FDA UDI
- Model / Reference
- 42520614-S FDA UDI
- Description
- ALIF CAGE FDA UDI
Identifiers
- Catalog Number
- 42520614-S FDA UDI
- Primary DI / UDI-DI
- 03700780629206 FDA UDI
- 510(k) Number
- K191263 FDA UDI
- FDA Product Code
- OVD 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
Yes
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
Dimensions & Sizes
- Size
- Height — 16 Millimeter FDA UDIAngle — 14 degree FDA UDIDepth — 26 Millimeter FDA UDIWidth — 32 Millimeter FDA UDI
Category: Polymeric spinal fusion cage, sterile
Idys®-ALIF TiVac by Clariance, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polymeric spinal fusion cage, sterile.
- TALOS® IBF — MEDITECH SPINE, LLC · Class II
- ROCCIA — Silony Medical GmbH · Class II
- TiNano — AURORA SPINE, INC. · Class II
- EVOS Lumbar Interbody System — CUTTING EDGE SPINE · Class II
- Aurora Spine — AURORA SPINE, INC. · 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
Cleared under the same submission
K191263 also covers:
- Idys®-ALIF TiVac — Clariance, Inc.
- Idys®-ALIF TiVac — Clariance, Inc.
- Idys®-ALIF TiVac — Clariance, Inc.
- Idys®-ALIF TiVac — Clariance, Inc.
- Idys®-ALIF TiVac — Clariance, Inc.
- Idys®-ALIF TiVac — Clariance, Inc.
- Idys®-ALIF TiVac — Clariance, Inc.
- Idys®-ALIF TiVac — Clariance, Inc.
- Idys®-ALIF TiVac — Clariance, Inc.
- Idys®-ALIF TiVac — Clariance, Inc.
- Idys®-ALIF TiVac — Clariance, Inc.
- Idys®-ALIF TiVac — Clariance, 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
- Clariance, Inc.
Sources (1)
- FDA UDI d6e1b0bd-5202-439f-a255-db01eeb4c689 37 fields · synced Jun 6, 2026