Catalog Number

-

Brand Name

Avenger Radial Head, +4 Stems

Version/Model Number

M70 SC365

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K212872

Product Code

KWI

Product Code Name

Prosthesis, Elbow, Hemi-, Radial, Polymer

Public Device Record Key

59b60dca-22e1-40b6-8ca2-32a867cca8e5

Public Version Date

February 07, 2022

Public Version Number

1

DI Record Publish Date

January 28, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-