FDA UDI
In Commercial Distribution
🇺🇸 United States
restor3d Kinos Axiom Total Ankle System
DI: 00840097505206
·
Model: 1831.2151
·
Restor3d, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- restor3d Kinos Axiom Total Ankle System
- Primary DI
- 00840097505206
- Version / Model
- 1831.2151
- Company Name
- Restor3d, Inc.
- Labeler DUNS
- 080819836
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-29
- Public Version
- 2
- Public Version Date
- 2023-11-02
- Public Version Status
- Update
- Public Device Record Key
- 75a4ee07-45d1-4ef7-8224-d3b4857995d6
Device Description
Tibial Implant, Size 5, Long Right, with Tidal Technology
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- No
- Has Lot/Batch Number
- Yes
- 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 | 00840097505206 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K192778 | 000 |