Catalog Number

370-5160-024

Brand Name

Ø7.0 x 24mm x 160mm CANNULATED PARTIAL THREAD SCREW

Version/Model Number

370-5160-024

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

K170021

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Public Device Record Key

1b19b55c-43a6-4f42-963d-b4e5fbde69fb

Public Version Date

June 22, 2020

Public Version Number

2

DI Record Publish Date

April 22, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-