FDA UDI
In Commercial Distribution
🇺🇸 United States
IVA Cage Ti
DI: 08800039816618
·
Model: A
·
DIOMEDICAL CO.,LTD.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- IVA Cage Ti
- Primary DI
- 08800039816618
- Version / Model
- A
- Catalog Number
- TTI.32110009
- Company Name
- DIOMEDICAL CO.,LTD.
- Labeler DUNS
- 557795909
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-06-19
- Public Version
- 6
- Public Version Date
- 2025-11-20
- Public Version Status
- Update
- Public Device Record Key
- ddf27988-ccca-419b-b3f0-f8b3d530ed68
Device Description
Transforaminal Lumbar Interbody Fusion Straight Titanium CageL32 x W11 x H9 x A0
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MAX | Intervertebral fusion device with bone graft, lumbar | Orthopedic | 888.3080 | 2 |
| ODP | Intervertebral fusion device with bone graft, cervical | Orthopedic | 888.3080 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46653 | Spinal fixation plate, non-bioabsorbable | A small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization as part of treatment of a spinal instability or deformity; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08800039816618 | GS1 |
Customer Contacts
- Phone
- +82313699470 ext. 112
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K173080 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 9 | Millimeter |