FDA UDI
In Commercial Distribution
🇺🇸 United States
Vantage
DI: 10885862622808
·
Model: 03-LMR-10-0005
·
Exactech, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Vantage
- Primary DI
- 10885862622808
- Version / Model
- 03-LMR-10-0005
- Catalog Number
- 03-LMR-10-0005
- Company Name
- Exactech, Inc.
- Labeler DUNS
- 157565946
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-28
- Public Version
- 1
- Public Version Date
- 2024-09-05
- Public Version Status
- New
- Public Device Record Key
- 4e8f5e0a-3f70-48b4-8f7c-3866a5f70a9d
Device Description
FIXED BEARING TIBIAL PLATE, 3D Tibia
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HSN | PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER | Orthopedic | 888.3110 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33718 | Fixed-bearing total ankle prosthesis | A sterile implantable artificial substitute for an ankle joint designed to replace the main articulating surfaces of the damaged (e.g., fractured) and/or degenerative (e.g., arthritic) joint. It includes tibial and talar components typically with parts made of metal and polyethylene (PE); the PE bearing that articulates the two components is attached or moulded to one of the components. Fixation devices (e.g., screws) for implantation may be included and implantation may be performed with or without bone cement. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10885862622808 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K230717 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 45 | Millimeter | |
| Device Size Text, specify | 10MM Cage Height | ||
| Device Size Text, specify | Size 5 | ||
| Device Size Text, specify | Right | ||
| Width | 36 | Millimeter |