Duns Number:080277500
Device Description: The Actua Knee is a polycentric pneumatic knee joint with stance flexion feature and non-a The Actua Knee is a polycentric pneumatic knee joint with stance flexion feature and non-adjustable spring extension assist. The stance flexion can be tuned infinitely, which ensures optimal comfort during loading response. The particularly long steering knuckles ensure high stability as well as a high flexion angle of the knee-joint.
Catalog Number
CA603-PPN
Brand Name
Actua Knee Pneumatic
Version/Model Number
CA603-PPN
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ISY
Product Code Name
Joint, Knee, External Limb Component
Public Device Record Key
39acc087-5b1b-4bcb-9d16-ca9d080893bc
Public Version Date
December 10, 2019
Public Version Number
1
DI Record Publish Date
December 02, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 88 |