FDA Registration
Active
🇺🇸 United States
ARCH Medical Solutions - Seabrook
Reg #: 1221763
·
FEI: 1221763
·
Expires 2025
Products
10
Proprietary Names
0
Establishment Types
1
Classifications
10
Registration Details
- Registration Name
- ARCH Medical Solutions - Seabrook
- Registration Number
- 1221763
- FEI Number
- 1221763
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 15 WOODWORKERS WAY
- City
- SEABROOK
- State
- NH
- ZIP
- 03874
- Country
- US
Regulatory Submissions
- 510(k) Number
- K110400
Owner / Operator
- Firm Name
- ARCH Medical Solutions - Seabrook
- Operator Number
- 1221763
- Address
- 15 Woodworker's Way, --
- City
- Seabrook
- State
- NH
- Postal Code
- 03874
- Country
- US
- Correspondent
- Dawn E Frazer
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | KWA | Class 3 | Orthopedic | No | 2021-04-20 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2021-04-20 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2021-04-20 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2021-04-20 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2021-04-20 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2021-04-20 |
| Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | JDL | Class 3 | Orthopedic | No | 2021-04-20 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2021-04-20 |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2021-04-20 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2021-04-20 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)