Catalog Number

402069

Brand Name

KneeAlign 2

Version/Model Number

402069

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

-

Product Code

OLO

Product Code Name

Orthopedic Stereotaxic Instrument

Public Device Record Key

078b4dee-a4c7-4ba3-ab8c-101e46e3f1ef

Public Version Date

March 21, 2022

Public Version Number

6

DI Record Publish Date

September 23, 2016

Package DI Number

00851977007161

Quantity per Package

2

Contains DI Package

00858704006459

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

2-Pack (P/N 402394)