FDA UDI
In Commercial Distribution
🇺🇸 United States
Balanced Knee Revision System
DI: 00822409096350
·
Model: 561-5246
·
Ortho Development Corporation
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Balanced Knee Revision System
- Primary DI
- 00822409096350
- Version / Model
- 561-5246
- Company Name
- Ortho Development Corporation
- Labeler DUNS
- 876542390
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-10-27
- Public Version
- 2
- Public Version Date
- 2024-02-28
- Public Version Status
- Update
- Public Device Record Key
- db3115ad-8e93-425e-8997-2b0c23dc747b
Device Description
Femoral Sleeve 46mm M-L 22mm A-P
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
- Yes
- 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 |
|---|---|---|---|---|
| MBH | PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER | Orthopedic | 888.3565 | 2 |
| JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | Orthopedic | 888.3560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61556 | Sleeve femoral/tibial extension, coated | A sterile implantable device typically designed to be attached to a revision femoral stem, knee femur prosthesis, femur/tibia shaft prosthesis, or body femoral/tibial extension stem to extend length to make up for bone loss during revision arthroplasty or bone resection. The device is a hollow sleeve made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel] and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws and bolts) may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00822409096350 | GS1 |
Customer Contacts
- Phone
- +1(801)553-9991
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K181569 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 22 | Millimeter | |
| Length | 46 | Millimeter | |
| Height | 59.5 | Millimeter |