FDA UDI
In Commercial Distribution
🇺🇸 United States
Klassic Knee Tibial Stem Extension, 125mm
DI: 00814703011504
·
Model: 5600.00.125
·
TOTAL JOINT ORTHOPEDICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Klassic Knee Tibial Stem Extension, 125mm
- Primary DI
- 00814703011504
- Version / Model
- 5600.00.125
- Company Name
- TOTAL JOINT ORTHOPEDICS, INC.
- Labeler DUNS
- 078416717
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-22
- Public Version
- 5
- Public Version Date
- 2022-05-09
- Public Version Status
- Update
- Public Device Record Key
- 4b2c7c85-32a8-4e3a-98ac-6cc2641c2032
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
- Yes
- Sterilization Methods
- Radiation Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | Orthopedic | 888.3560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64152 | Knee tibia stem prosthesis | An implantable uncoated shaft-like device intended to be attached to the tibial baseplate of a modular knee tibia prosthesis to provide anchorage within the tibia. It has a threaded proximal end and is shaped to provide a tight fit with the internal tibial cortex; it is made of metallic materials. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00814703011504 | GS1 |
Customer Contacts
- Phone
- +1(801)486-6070
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K140942 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 125mm |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- The Klassic Knee System should be stored in a clean, dry location at room temperature