Identity
- Trade Name
- Rheo Knee FDA UDI
- Generic Name
- Mechatronic external knee prosthesis FDA UDI
- Device Name
- RHEO KNEE 3 W LOCK LOANER FDA UDI
- Model / Reference
- RKN13110 FDA UDI
- Description
- RHEO KNEE 3 W LOCK LOANER FDA UDI
Identifiers
- Catalog Number
- RKN13110 FDA UDI
- Primary DI / UDI-DI
- 05690967600587 FDA UDI
- FDA Product Code
- ISY FDA UDI
- GMDN Term
- Mechatronic external knee prosthesis FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3420 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
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Mechatronic external knee prosthesis
Rheo Knee by Ossur Americas — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Ossur Americas
Sources (1)
- FDA UDI cbb0bfc2-ffb0-4b35-b516-7d6d50ed669f 35 fields · synced Jun 8, 2026