Catalog Number

-

Brand Name

ION Facet Screw System

Version/Model Number

TI-AE-60-45

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

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

K211855

Product Code

MRW

Product Code Name

System, Facet Screw Spinal Device

Public Device Record Key

44034bae-09d7-4d69-bcc6-9171bf9744ba

Public Version Date

April 28, 2022

Public Version Number

1

DI Record Publish Date

April 20, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-