FDA Registration
Active
🇬🇧 United Kingdom
Zimmer (DV,RG) - G7 Freedom And Offset Liners, Freedom Head, Size 32
Reg #: 3002807315
·
FEI: 3002807315
·
Expires 2025
Products
8
Proprietary Names
1
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- SYNERGY HEALTH STERILISATION UK LTD
- Registration Number
- 3002807315
- FEI Number
- 3002807315
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Drayton Fields Industrial Estate, Brunel Close
- City
- Daventry Northamptonshire
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K142882
Owner / Operator
- Firm Name
- STERIS Corporation
- Operator Number
- 10042227
- Address
- 5960 Heisley Road
- City
- Mentor
- State
- OH
- Postal Code
- 44060
- Country
- US
US Agent
- Business Name
- Synergy Health
- Contact Name
- Becky Aldhizer
- Address
- 5960 Heisley Rd
- City
- Mentor
- State
- OH
- ZIP
- 44060
- Country
- US
- [email protected]
- Phone
- 440 3927490
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2022-03-31 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2022-03-31 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2022-03-31 |
| Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | OQI | Class 2 | Orthopedic | No | 2022-03-31 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive | PBI | Class 2 | Orthopedic | No | 2022-03-31 |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2022-03-31 |
| Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented | OQH | Class 2 | Orthopedic | No | 2022-03-31 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2022-03-31 |
Proprietary Names
Zimmer (DV,RG) - G7 Freedom And Offset Liners, Freedom Head, Size 32
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)