Identity
- Trade Name
- Quadsense FDA UDI
- Generic Name
- Arthroplasty force sensor FDA UDI
- Device Name
- Single use sensor FDA UDI
- Model / Reference
- SE001 FDA UDI
- Description
- Single use sensor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05065012584158 FDA UDI
- 510(k) Number
- FDA Product Code
- ONN FDA 510(k)FDA UDI
- GMDN Term
- Arthroplasty force sensor FDA UDI
Classification
- Device Class
- Class II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 882.4560 FDA 510(k)
- Regulation Number
- 882.4560 FDA 510(k)FDA UDI
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Quadsense by Eventum Orthopaedics Ltd — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K241298 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Eventum Orthopaedics Ltd
- FDA Applicant
- Eventum Orthopaedics, Ltd.
Sources (2)
- FDA 510(k) K241298 24 fields · synced Jun 18, 2026
- FDA UDI bec7d621-96a6-4930-9d94-c35033a88ab4 36 fields · synced May 26, 2026