Catalog Number

GRU-RL/LM-4F-C

Brand Name

GRU Femur

Version/Model Number

GRU-RL/LM-4F-C

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 14, 2021

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

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

K051721

Product Code

HRY

Product Code Name

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

Public Device Record Key

9b1fdd76-1b13-4ea2-842c-7a1a056f9ea1

Public Version Date

July 14, 2021

Public Version Number

4

DI Record Publish Date

March 09, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-