Catalog Number

-

Brand Name

Cortex Screw, 3.5mm x 22mm, T15, Flex-Thread™

Version/Model Number

8428-22-S

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

K202858

Product Code

HSB

Product Code Name

ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Public Device Record Key

8385c3ca-8a6f-422e-ae0c-6b137e890bf6

Public Version Date

March 29, 2021

Public Version Number

1

DI Record Publish Date

March 19, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-