Catalog Number

001-037

Brand Name

Aurora Spine

Version/Model Number

ZIP

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K133091

Product Code

PEK

Product Code Name

Spinous Process Plate

Public Device Record Key

3fe661bf-ac54-4b73-9b4f-dfe1c8da75f8

Public Version Date

June 10, 2019

Public Version Number

1

DI Record Publish Date

June 01, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-