Catalog Number

100-9816

Brand Name

Superion Interspinous Spacer

Version/Model Number

16mm

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 17, 2020

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

-

Product Code

NQO

Product Code Name

Prosthesis, Spinous Process Spacer/Plate

Public Device Record Key

1085fffb-2e07-4cc4-9552-8f61cae71d0a

Public Version Date

August 05, 2022

Public Version Number

5

DI Record Publish Date

February 10, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-