Catalog Number

PWL2-1005-W

Brand Name

WaveKahuna™

Version/Model Number

PWL2-1005-W

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

Yes

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

K181280

Product Code

KRR

Product Code Name

Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer

Public Device Record Key

88f4b999-a650-403c-8ccb-6da0b07e969c

Public Version Date

March 20, 2020

Public Version Number

1

DI Record Publish Date

March 12, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-