Catalog Number

PK230010

Brand Name

Power Knee

Version/Model Number

PK230010

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

ISW

Product Code Name

ASSEMBLY, KNEE/SHANK/ANKLE/FOOT, EXTERNAL

Public Device Record Key

a08f2269-5553-4cb1-be91-e1c91524acbc

Public Version Date

June 11, 2018

Public Version Number

1

DI Record Publish Date

May 11, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-