Identity
- Trade Name
- Actua Knee Hydraulic FDA UDI
- Generic Name
- Polycentric mechanical knee prosthesis FDA UDI
- Device Name
- The Actua Knee Hydraulic is a polycentric hydraulic knee joint with stance flexion feature and interchangeable spring extension assist. The stance flexion can be tuned infinitely, which ensures optimal comfort during loading response. The patented horizontal hydraulic cylinder contributes to the compact size of this hydraulic knee joint. In addition, maintenance is easy with the innovative oil-refill system. FDA UDI
- Model / Reference
- CA603-PHY FDA UDI
- Description
- The Actua Knee Hydraulic is a polycentric hydraulic knee joint with stance flexion feature and interchangeable spring extension assist. The stance flexion can be tuned infinitely, which ensures optimal comfort during loading response. The patented horizontal hydraulic cylinder contributes to the compact size of this hydraulic knee joint. In addition, maintenance is easy with the innovative oil-refill system. FDA UDI
Identifiers
- Catalog Number
- CA603-PHY FDA UDI
- Primary DI / UDI-DI
- 00850013242320 FDA UDI
- FDA Product Code
- ISY FDA UDI
- GMDN Term
- Polycentric mechanical 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
No
FDA UDI
Category: Polycentric mechanical knee prosthesis
Actua Knee Hydraulic by Cypress Adaptive, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polycentric mechanical knee prosthesis.
- Actua Knee Pneumatic — CYPRESS ADAPTIVE, LLC · Class I
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
- Cypress Adaptive, Llc
Sources (1)
- FDA UDI 98dd1145-7410-4585-bb6a-94db41cd8250 34 fields · synced May 30, 2026