Identity
- Trade Name
- IVA FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system, non-sterile FDA UDI
- Device Name
- DLIF DISTRACTOR L50 x W18 x H15 FDA UDI
- Model / Reference
- A FDA UDI
- Description
- DLIF DISTRACTOR L50 x W18 x H15 FDA UDI
Identifiers
- Catalog Number
- DI.0531 FDA UDI
- Primary DI / UDI-DI
- 08809489297756 FDA UDI
- 510(k) Number
- K162220 FDA UDI
- FDA Product Code
- ODP FDA UDIMAX FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system, non-sterile 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: Bone-screw internal spinal fixation system, non-sterile
Iva by Dio Medical Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone-screw internal spinal fixation system, non-sterile.
- TIGER Spine System — CORELINK LLC · Class II
- The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
- SILVERTON SPINAL FIXATION SYSTEM — BIOMET SPINE LLC · Class II
- POLARIS™ 5.5 SPINAL SYSTEM — BIOMET SPINE LLC · Class II
- Vitality® — BIOMET SPINE LLC · Class II
- The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
- PASS LP — Medicrea International SA · Class II
- The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · 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 |
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Manufacturer
- Manufacturer
- Dio Medical Co., Ltd.
Sources (1)
- FDA UDI 74bdf2b9-24a0-4948-ad0f-059bbac38aa3 36 fields · synced May 30, 2026