Identity
- Trade Name
- Panel PC FDA UDI
- Generic Name
- Arthroplasty force sensor display unit FDA UDI
- Device Name
- Medical computer loaded with Quadsense software. FDA UDI
- Model / Reference
- PC001 FDA UDI
- Description
- Medical computer loaded with Quadsense software. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05065012584516 FDA UDI
- 510(k) Number
- K241298 FDA UDI
- FDA Product Code
- ONN FDA UDI
- GMDN Term
- Arthroplasty force sensor display unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Arthroplasty force sensor display unit
Panel PC by Eventum Orthopaedics Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K241298 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Eventum Orthopaedics Ltd
Sources (1)
- FDA UDI addef1c8-6b4e-47dd-8869-3aafbfebc842 36 fields · synced Jun 8, 2026