Catalog Number

00-5964-013-52

Brand Name

NexGen® Legacy®

Version/Model Number

5964-13-52

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

P060037,K173057,K991581,P060037,P060037,P060037

Product Code

JWH

Product Code Name

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

Public Device Record Key

fc23d10a-21f1-47be-bbe2-70d23af8c2e9

Public Version Date

July 28, 2022

Public Version Number

6

DI Record Publish Date

January 10, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-