Catalog Number

-

Brand Name

Zavation

Version/Model Number

240-2005-1

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

-

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

K173752

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Public Device Record Key

9cd0f0af-fb6a-4a17-a03f-89bb7fe78fbf

Public Version Date

May 24, 2021

Public Version Number

1

DI Record Publish Date

May 14, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-