FDA Registration
Active
🇺🇸 United States
Pipeline Total Hip System
Reg #: 1226544
·
FEI: 3003128516
·
Expires 2025
Products
7
Proprietary Names
1
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- MILLSTONE MEDICAL OUTSOURCING LLC.
- Registration Number
- 1226544
- FEI Number
- 3003128516
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 580 Commerce Dr
- City
- FALL RIVER
- State
- MA
- ZIP
- 02720
- Country
- US
Regulatory Submissions
- 510(k) Number
- K122158
Owner / Operator
- Firm Name
- MILLSTONE MEDICAL OUTSOURCING LLC.
- Operator Number
- 9042927
- Address
- 580 Commerce Drive
- City
- Fall River
- State
- MA
- Postal Code
- 02720
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2015-08-19 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2015-08-19 |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2015-08-19 |
| Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented | OQH | Class 2 | Orthopedic | No | 2015-08-19 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2015-08-19 |
| Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | OQI | Class 2 | Orthopedic | No | 2015-08-19 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2015-08-19 |
Proprietary Names
Pipeline Total Hip System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)