Catalog Number

-

Brand Name

Stealthfix Intraosseous Fixation System

Version/Model Number

SF3538

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K220181

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Public Device Record Key

920c813c-3a6e-4e4b-b2c0-4e543044c94d

Public Version Date

September 23, 2022

Public Version Number

2

DI Record Publish Date

August 04, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-