Identity
- Trade Name
- IVA Cage FDA UDI
- Generic Name
- Spinal fixation plate, non-bioabsorbable FDA UDI
- Device Name
- ACDF L12 x W14 x A15 x H08 FDA UDI
- Model / Reference
- A FDA UDI
- Description
- ACDF L12 x W14 x A15 x H08 FDA UDI
Identifiers
- Catalog Number
- ACF.12141508 FDA UDI
- Primary DI / UDI-DI
- 08800039830782 FDA UDI
- 510(k) Number
- K162220 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
Category: Spinal fixation plate, non-bioabsorbable
IVA Cage 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.
- Zavation — ZAVATION · Class II
- Cervalign — Xtant Medical Holdings, Inc. · Class II
- CODA™ Anterior Cervical Plate System — Pioneer Surgical Technology, Inc. · Class II
- TSLP — Synthes · Class II
- AESCULAP — AESCULAP, INC. · Class II
- 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
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dio Medical Co., Ltd.
Sources (1)
- FDA UDI 33d034dc-47a8-4d01-b93f-cf322e96fe72 36 fields · synced May 31, 2026