Catalog Number

3A17

Brand Name

Modular Single Axis Knee Joint

Version/Model Number

3A17

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

ISY

Product Code Name

Joint, Knee, External Limb Component

Public Device Record Key

e0d37793-ffac-43aa-b6f8-344466b9211c

Public Version Date

November 11, 2020

Public Version Number

1

DI Record Publish Date

November 03, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-