Catalog Number

402068

Brand Name

KneeAlign 2

Version/Model Number

402068

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

0438adf8-7f0a-413e-97a6-5728633d06f7

Public Version Date

March 21, 2022

Public Version Number

6

DI Record Publish Date

September 23, 2016

Package DI Number

00851977007178

Quantity per Package

2

Contains DI Package

00858704006442

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

2-Pack (PN 402395)