Catalog Number

-

Brand Name

ARIX System Bone Screw

Version/Model Number

28L-SO-L08-TA

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

K161864,K201656

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Public Device Record Key

a66395ed-d112-43f7-a9d8-19834b185345

Public Version Date

October 27, 2020

Public Version Number

1

DI Record Publish Date

October 19, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-