Catalog Number

05000-004

Brand Name

LinkStation MINI

Version/Model Number

LinkStation MINI

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

K150372

Product Code

ONN

Product Code Name

Intraoperative Orthopedic Joint Assessment Aid

Public Device Record Key

aef70765-137c-4320-99aa-3921e22b137c

Public Version Date

October 24, 2022

Public Version Number

5

DI Record Publish Date

February 20, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-