Identity
- Trade Name
- IVA Cage FDA UDI
- Generic Name
- Spinal implant trial FDA UDI
- Device Name
- DLIF Trial L45 x W18 x A0 x H17 FDA UDI
- Model / Reference
- A FDA UDI
- Description
- DLIF Trial L45 x W18 x A0 x H17 FDA UDI
Identifiers
- Catalog Number
- DI.2044 FDA UDI
- Primary DI / UDI-DI
- 08809489299620 FDA UDI
- 510(k) Number
- K162220 FDA UDI
- FDA Product Code
- ODP FDA UDIMAX FDA UDI
- GMDN Term
- Spinal implant trial 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
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Spinal implant trial
IVA Cage by Dio Medical Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K162220 also covers:
- IVA — Dio Medical Co., Ltd.
- IVA — Dio Medical Co., Ltd.
- IVA — Dio Medical Co., Ltd.
- IVA — Dio Medical Co., Ltd.
- IVA — Dio Medical Co., Ltd.
- IVA — Dio Medical Co., Ltd.
- IVA — Dio Medical Co., Ltd.
- IVA — Dio Medical Co., Ltd.
- IVA — Dio Medical Co., Ltd.
- IVA — Dio Medical Co., Ltd.
- IVA — Dio Medical Co., Ltd.
- IVA — 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 99251edb-90f8-4c1e-8e12-31eff4bab508 36 fields · synced Jun 8, 2026