FDA UDI
In Commercial Distribution
🇺🇸 United States
GMK Primary Total Knee System
DI: 07630030819940
·
Model: 02.07.1206L
·
Medacta International SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- GMK Primary Total Knee System
- Primary DI
- 07630030819940
- Version / Model
- 02.07.1206L
- Company Name
- Medacta International SA
- Labeler DUNS
- 488227125
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-11-18
- Public Version
- 4
- Public Version Date
- 2019-12-11
- Public Version Status
- Update
- Public Device Record Key
- 36c3f71b-7296-4d1d-884a-e6b56959ea4a
Device Description
Fixed tibial tray cemented left, size 6
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 |
|---|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | 888.3560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32832 | Uncoated knee tibia prosthesis, metallic | An implantable device designed to replace the tibial condyles (tibial component) during primary bicondylar replacement of the knee joint, femoral bone resection, or to replace a dysfunctional knee prosthesis (revision); it is made of metal [e.g., cobalt-chrome (Co-Cr), cobalt-chrome-molybdenum (Co-Cr-Mo), titanium (Ti)] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth. The device is designed to articulate with an insert and/or the femoral prosthetic component of the knee joint and its implantation is intended to be performed with bone cement. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07630030819940 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K090988 | 000 |