Catalog Number

ST360178HA

Brand Name

ST.A.R. 90 F4

Version/Model Number

HA cortical bone screw ø6mm L180-35mm

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

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

K150661

Product Code

JDW

Product Code Name

Pin, Fixation, Threaded

Public Device Record Key

10a0e5ec-75a7-448f-a7af-5caa75b31949

Public Version Date

July 07, 2022

Public Version Number

1

DI Record Publish Date

June 29, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-