FDA Registration
Active
🇬🇧 United Kingdom
Quadsense
Reg #: 3033434191
·
FEI: 3033434191
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- EVENTUM ORTHOPAEDICS LTD
- Registration Number
- 3033434191
- FEI Number
- 3033434191
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Richmond House, Lawnswood Business Park
- City
- Leeds
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K241298
Owner / Operator
- Firm Name
- Eventum Orthopaedics Ltd
- Operator Number
- 10091583
- Address
- Richmond House, Lawnswood Business Park
- City
- Leeds
- State
- GB-LDS
- Postal Code
- LS16 6QY
- Country
- GB
- Correspondent
- John Naybour
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intraoperative Orthopedic Joint Assessment Aid | ONN | Class 2 | Neurology | No | 2024-10-17 |
Proprietary Names
Quadsense
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device