Catalog Number

-

Brand Name

Evolve Broach

Version/Model Number

111-162-105

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

K133370

Product Code

JDI

Product Code Name

Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Public Device Record Key

3a764b17-9a26-485f-9ed5-dc51b3425042

Public Version Date

September 23, 2020

Public Version Number

2

DI Record Publish Date

October 09, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-