Catalog Number

50-20358E

Brand Name

NA

Version/Model Number

50-20358E

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

K050535

Product Code

DZL

Product Code Name

SCREW, FIXATION, INTRAOSSEOUS

Public Device Record Key

3b86d11c-e87c-4446-9fd8-860578673de0

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 11, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-