FDA UDI
In Commercial Distribution
🇺🇸 United States
Klassic Knee Sombrero Patella
DI: 00814703016776
·
Model: 5501.05.010
·
TOTAL JOINT ORTHOPEDICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Klassic Knee Sombrero Patella
- Primary DI
- 00814703016776
- Version / Model
- 5501.05.010
- Company Name
- TOTAL JOINT ORTHOPEDICS, INC.
- Labeler DUNS
- 078416717
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-04-08
- Public Version
- 3
- Public Version Date
- 2021-02-05
- Public Version Status
- Update
- Public Device Record Key
- 9d459352-290a-41e1-8e90-90ac2d624d1d
Device Description
Knee Sombrero Patella, Size 5, 10mm
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
- Ethylene Oxide
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 |
|---|---|---|---|---|
| 34199 | Polyethylene patella prosthesis | An implantable device made of polyethylene (PE) intended to fully or partially replace the patella (kneecap) as part of a bicondylar knee joint replacement (primary or revision). It is designed to articulate with a prosthetic distal femoral component by attachment to the back of the natural patella with or without bone cement. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00814703016776 | GS1 |
Customer Contacts
- Phone
- +1(801)486-6070
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K190280 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 5501.05.010 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- The Klassic Knee System should be stored in a clean, dry location at room temperature