FDA UDI
In Commercial Distribution
🇺🇸 United States
FREEDOM STEMMED
DI: 00811767024907
·
Model: RAUUX000-RK
·
MAXX ORTHOPEDICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- FREEDOM STEMMED
- Primary DI
- 00811767024907
- Version / Model
- RAUUX000-RK
- Company Name
- MAXX ORTHOPEDICS, INC.
- Labeler DUNS
- 792030103
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-07
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- f43206b2-869d-47c4-921d-e8000b189e87
Device Description
Tibial Augment Size 0
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
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| 58228 | Bicompartmental knee prosthesis | A sterile implantable device designed to replace the patellofemoral and medial tibiofemoral articulating surfaces of a damaged/degenerative (e.g., arthritic) knee during primary or revision bicompartmental replacement of the joint; it is intended to permit retention of the lateral tibiofemoral compartment and both cruciate ligaments. The device is made of metal [e.g., oxidized zirconium alloy, cobalt-chrome (Co-Cr)] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth; 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 | 00811767024907 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K111785 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 26.6 | Millimeter | |
| Length | 36.2 | Millimeter |