AccessGUDID - DEVICE: Actua Knee Pneumatic (00850013242313)

GUDID

Device Identifier (DI) Information

Brand Name: Actua Knee Pneumatic
Version or Model: CA603-PPN
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CA603-PPN
Company Name: CYPRESS ADAPTIVE, LLC

Primary DI Number: 00850013242313
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080277500 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
43795	Polycentric mechanical knee prosthesis	An artificial substitute for a transfemoral (above-the-knee) and/or knee disarticulation amputation designed as a component of an external lower-limb prosthesis to restore some of the appearance and/or function of the normal anatomy. It typically consists of metal and plastic and is constructed as a multiple-axis joint rotation, mechanical hinge that incorporates friction adjustment and a simple swing control that permits variable walking speed. A common design, known as a “fourbar” knee, is very stable during early stance phase (beginning of a step), reduces the leg’s length when beginning a step lowering the risk of stumbling, and bends in the swing phase or when the user sits down.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
ISY	Joint, Knee, External Limb Component

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

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