Catalog Number

-

Brand Name

Zavation

Version/Model Number

Z-1041

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

K112533

Product Code

KWQ

Product Code Name

Appliance, Fixation, Spinal Intervertebral Body

Public Device Record Key

ce281d14-221f-44da-be65-eb120037bd19

Public Version Date

July 20, 2022

Public Version Number

1

DI Record Publish Date

July 12, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-