FDA UDI
In Commercial Distribution
🇺🇸 United States
WaveKahuna™
DI: M528PWR21005W0
·
Model: PWR2-1005-W
·
ARTHROSURFACE INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- WaveKahuna™
- Primary DI
- M528PWR21005W0
- Version / Model
- PWR2-1005-W
- Catalog Number
- PWR2-1005-W
- Company Name
- ARTHROSURFACE INCORPORATED
- Labeler DUNS
- 144666109
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-12
- Public Version
- 1
- Public Version Date
- 2020-03-20
- Public Version Status
- New
- Public Device Record Key
- f142cdca-be8f-404f-ab61-9cb1847a466d
Device Description
Femoral Component, Right, 10.0mm Offset, Kahuna, CE
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
- 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 |
|---|---|---|---|---|
| KRR | Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | Orthopedic | 888.3540 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58992 | Partial-resurfacing knee femur prosthesis | A sterile implantable device, in the form of a small plug and stem, designed to treat focal lesions of the articular surface of the distal femur by excision of the lesion and uncemented fixation of the device in the surgically-prepared defect, with retention of the surrounding healthy articular cartilage. It is made of metal, may have a synthetic polymer articulating surface, and may be coated with a material intended to improve fixation and stability by promoting bone ingrowth. It is available in a range of sizes for treatment of different size lesions. Disposable devices associated with implantation may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M528PWR21005W0 | HIBCC |
Customer Contacts
- Phone
- 508-520-3003
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K181280 | 000 |