Identity
- Trade Name
- IVA Cage FDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- PLIF Tray FDA UDI
- Model / Reference
- A FDA UDI
- Description
- PLIF Tray FDA UDI
Identifiers
- Catalog Number
- PI.3000 FDA UDI
- Primary DI / UDI-DI
- 08809557208035 FDA UDI
- 510(k) Number
- K162220 FDA UDI
- FDA Product Code
- MAX FDA UDIODP FDA UDI
- GMDN Term
- General internal orthopaedic fixation system implantation kit 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: General internal orthopaedic fixation system implantation kit
IVA Cage by Dio Medical Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as General internal orthopaedic fixation system implantation kit.
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- ACUMED — ACUMED LLC · Class I
- OsteoMed — Osteomed Corp. · Class II
- ALEUTIAN® Interbody Systems — K2M, INC. · Class II
- HONOUR™ Spacer System — NEXXT SPINE LLC · 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 a1437376-7f08-4176-b177-387240809a59 36 fields · synced May 30, 2026