Catalog Number

WZ-1-1035

Brand Name

Uni Tibial Insert

Version/Model Number

4x14

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

K012800

Product Code

HRY

Product Code Name

Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

Public Device Record Key

5a33408e-441a-4a36-858d-c3327c3d0415

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

April 29, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-