FDA Registration
Active
🇺🇸 United States
SurgTech Bipolar
Reg #: 3011170410
·
FEI: 3011170410
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- SURGTECH, INC.
- Registration Number
- 3011170410
- FEI Number
- 3011170410
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 24600 Center Ridge Road, Suite 195
- City
- Westlake
- State
- OH
- ZIP
- 44145
- Country
- US
Regulatory Submissions
- 510(k) Number
- K173455
Owner / Operator
- Firm Name
- SurgTech, Inc.
- Operator Number
- 10047514
- Address
- 24600 Center Ridge Road, Suite 195
- City
- Westlake
- State
- OH
- Postal Code
- 44145
- Country
- US
- Correspondent
- Cheng Bao
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 | 2019-12-19 |
Proprietary Names
SurgTech Bipolar
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device