Identity
- Trade Name
- CAGE TLIF (W29 D11 H10 MM) EUDAMEDIdys™- LIF FDA UDI
- Generic Name
- Polymeric spinal fusion cage, sterile FDA UDI
- Device Name
- TLIF CAGE FDA UDI
- Model / Reference
- 06532910-S EUDAMEDFDA UDIIdys® TLIF EUDAMED
- Description
- TLIF CAGE FDA UDI
Identifiers
- Catalog Number
- 06532910-S FDA UDI
- Primary DI / UDI-DI
- 03700780600427 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03700780600427 EUDAMED
- 510(k) Number
- K131178 FDA UDI
- FDA Product Code
- MAX FDA UDI
- EMDN Code
- P09070101 SPINAL CAGES EUDAMED
- GMDN Term
- Polymeric spinal fusion cage, sterile FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3080 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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 — 10 Millimeter FDA UDIDepth — 11 Millimeter FDA UDIWidth — 29 Millimeter FDA UDI
Category: Polymeric spinal fusion cage, sterile
Idys™- LIF by Clariance, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — 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
K131178 also covers:
- Idys™- LIF — Clariance, Inc.
- Idys™- LIF — Clariance, Inc.
- Idys™- LIF — Clariance, Inc.
- Idys™- LIF — Clariance, Inc.
- Idys™- LIF — Clariance, Inc.
- Idys™- LIF — Clariance, Inc.
- Idys™- LIF — Clariance, Inc.
- Idys™- LIF — Clariance, Inc.
- Idys™- LIF — Clariance, Inc.
- Idys™- LIF — Clariance, Inc.
- Idys™- LIF — Clariance, Inc.
- Idys™- LIF — Clariance, Inc.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| 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
- Clariance, Inc.
Sources (2)
- FDA UDI 2ec77847-35b2-466d-a4da-f0d0f963f5d6 37 fields · synced Oct 8, 2026
- EUDAMED 8d75adb6-4e38-4c7c-8811-71af1dd7af3b 61 fields · synced Oct 8, 2026