FDA UDI
In Commercial Distribution
🇺🇸 United States
Alliant Biotech
DI: G611220910450
·
Model: Offset
·
MEDISURGE LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Alliant Biotech
- Primary DI
- G611220910450
- Version / Model
- Offset
- Catalog Number
- 22-09-10450
- Company Name
- MEDISURGE LLC
- Labeler DUNS
- 119198202
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-02
- Public Version
- 1
- Public Version Date
- 2024-08-12
- Public Version Status
- New
- Public Device Record Key
- e5d5c5c0-af29-41cb-882f-f2fccd801430
Device Description
Symmetric Total Knee Offset Trunnion
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| 62865 | Knee femur stem/sleeve connector | A sterile implantable device intended to provide a connection between a knee femur prosthesis and a knee stem or sleeve when the knee femur prosthesis does not have a connection point inherent in its design. It takes various forms including a plate and trunnion, or a cylinder, and is made of metal [e.g., cobalt-chrome (Co-Cr)]. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G611220910450 | HIBCC |
Customer Contacts
- Phone
- 8883071144
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K100370 | 000 |