FDA UDI
In Commercial Distribution
🇺🇸 United States
MISHA(TM) Knee System, Small, Right
DI: 00856047005801
·
Model: 102740
·
Moximed, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MISHA(TM) Knee System, Small, Right
- Primary DI
- 00856047005801
- Version / Model
- 102740
- Catalog Number
- 2-1002
- Company Name
- Moximed, Inc.
- Labeler DUNS
- 808178383
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-05
- Public Version
- 1
- Public Version Date
- 2023-05-15
- Public Version Status
- New
- Public Device Record Key
- 250e8d15-1fec-4060-a001-46f27b594a05
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
- Yes
- 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 |
|---|---|---|---|---|
| QVV | Medial Knee Implanted Shock Absorber | Orthopedic | 888.3610 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60373 | Implantable knee unloader | A sterile, implantable metallic device intended to reduce the load on the medial compartment of the knee for the treatment of degenerative articular cartilage (e.g., osteoarthritis) without any other alteration to the joint (i.e., no other arthroplasty or prosthesis implant). It typically consists of bases fixed to the medial side of the femoral and tibial condyles, which hold in place a spring-like absorber designed to absorb, redistribute or shift loads on the medial knee compartment. The implant is subcutaneous and extracapsular, and is typically introduced through small skin incisions. It is typically supplied with the required screws and surgical instruments necessary for implantation. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00856047005801 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN220033 | 000 |