FDA Registration
Active
🇺🇸 United States
G7 Dual Mobility System
Reg #: 1835572
·
FEI: 3001452082
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- MAITLAND ENGINEERING
- Registration Number
- 1835572
- FEI Number
- 3001452082
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2713 Foundation Dr
- City
- South Bend
- State
- IN
- ZIP
- 46628
- Country
- US
Regulatory Submissions
- 510(k) Number
- K150522
Owner / Operator
- Firm Name
- Maitland Engineering
- Operator Number
- 10042537
- Address
- 2713 Foundation Drive
- City
- South Bend
- State
- IN
- Postal Code
- 46628
- Country
- US
- Correspondent
- Scott M Beehler
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2021-03-16 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2021-03-16 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2021-03-16 |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2021-03-16 |
Proprietary Names
G7 Dual Mobility System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)