Catalog Number

101-9808

Brand Name

Superion Indirect Decompression System

Version/Model Number

8mm

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

P140004,P140004,P140004,P140004,P140004,P140004

Product Code

NQO

Product Code Name

Prosthesis, Spinous Process Spacer/Plate

Public Device Record Key

7bc29e20-8019-4380-b665-2d8ddfaeca19

Public Version Date

February 11, 2022

Public Version Number

5

DI Record Publish Date

September 28, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-