FDA UDI
In Commercial Distribution
🇺🇸 United States
Kinos Axiom
DI: 00850022178337
·
Model: 3801.2112
·
Restor3d, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Kinos Axiom
- Primary DI
- 00850022178337
- Version / Model
- 3801.2112
- Catalog Number
- 3801.2112
- Company Name
- Restor3d, Inc.
- Labeler DUNS
- 080819836
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-10-12
- Public Version
- 3
- Public Version Date
- 2023-11-02
- Public Version Status
- Update
- Public Device Record Key
- 0339e34c-9dc1-414c-82cb-17a6a37d97ed
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
- 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 |
|---|---|---|---|---|
| 48180 | Ankle prosthesis bearing | A sterile implantable device made of polyethylene (PE) designed to articulate the tibial and talar components of a total ankle prosthesis. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850022178337 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K192778 | 000 |