Catalog Number

-

Brand Name

Irix-A Lumbar Integrated Fusion System

Version/Model Number

C080-0078

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

-

Product Code

HWA

Product Code Name

IMPACTOR

Public Device Record Key

9486d82c-cb50-415a-b331-9f81709e17dd

Public Version Date

June 03, 2021

Public Version Number

4

DI Record Publish Date

April 01, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-