FDA Registration
Active
🇮🇪 Ireland
Dall Miles Cable System
Reg #: 9610726
·
FEI: 3002807172
·
Expires 2025
Products
9
Proprietary Names
3
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- HOWMEDICA INTERNATIONAL S. DE R.L.,
- Registration Number
- 9610726
- FEI Number
- 3002807172
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- RAHEEN BUSINESS PARK
- City
- LIMERICK Munster
- Country
- IE
Regulatory Submissions
- 510(k) Number
- K240418
Owner / Operator
- Firm Name
- STRYKER CORP.
- Operator Number
- 1811755
- Address
- 4100 East Milham Ave.
- City
- Kalamazoo
- State
- MI
- Postal Code
- 49001
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2024-05-01 |
| Cerclage, Fixation | JDQ | Class 2 | Orthopedic | No | 2024-05-01 |
| Prosthesis, Hip, Femoral Component, Cemented, Metal | JDG | Class 2 | Orthopedic | No | 2024-05-01 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2024-05-01 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2024-05-01 |
| Wire, Surgical | LRN | Class 2 | Orthopedic | No | 2024-05-01 |
| Fixation Accessory | LYT | Class 2 | Orthopedic | No | 2024-05-01 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2024-05-01 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2024-05-01 |
Proprietary Names
Dall Miles Cable System
Orthinox V40 Femoral Heads
Exeter Hip System
Establishment Types
Manufacture Medical Device