Identity
- Trade Name
- IVA Cage Ti FDA UDI
- Generic Name
- Spinal fixation plate, non-bioabsorbable FDA UDI
- Device Name
- Transforaminal Lumbar Interbody Fusion Curved Titanium CageL36 x W10 x H12 x A8 FDA UDI
- Model / Reference
- A FDA UDI
- Description
- Transforaminal Lumbar Interbody Fusion Curved Titanium CageL36 x W10 x H12 x A8 FDA UDI
Identifiers
- Catalog Number
- TTC.36100812 FDA UDI
- Primary DI / UDI-DI
- 08800039817813 FDA UDI
- 510(k) Number
- K173080 FDA UDI
- FDA Product Code
- ODP FDA UDIMAX FDA UDI
- GMDN Term
- Spinal fixation plate, non-bioabsorbable 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
Yes
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Height — 12 Millimeter FDA UDI
Category: Spinal fixation plate, non-bioabsorbable
IVA Cage Ti by Dio Medical Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spinal fixation plate, non-bioabsorbable.
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- PROVIDENCE — GLOBUS MEDICAL, INC. · Class II
- ACP — Nuvasive, Inc. · Class II
- uNion Cervical Plate System — ULRICH MEDICAL USA, INC. · Class II
Cleared under the same submission
K173080 also covers:
- IVA Cage Ti — Dio Medical Co., Ltd.
- IVA Cage Ti — Dio Medical Co., Ltd.
- IVA Cage Ti — Dio Medical Co., Ltd.
- IVA Cage Ti — Dio Medical Co., Ltd.
- IVA Cage Ti — Dio Medical Co., Ltd.
- IVA Cage Ti — Dio Medical Co., Ltd.
- IVA Cage Ti — Dio Medical Co., Ltd.
- IVA Cage Ti — Dio Medical Co., Ltd.
- IVA Cage Ti — Dio Medical Co., Ltd.
- IVA Cage Ti — Dio Medical Co., Ltd.
- IVA Cage Ti — Dio Medical Co., Ltd.
- IVA Cage Ti — Dio Medical Co., Ltd.
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
- Dio Medical Co., Ltd.
Sources (1)
- FDA UDI 0eed9185-3dd7-49d8-8422-4302eee6ffdd 37 fields · synced May 31, 2026