Catalog Number

14-500805E

Brand Name

Polaris™ 5.5 Spinal System

Version/Model Number

14-500805E

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

-

Product Code

KWP

Product Code Name

APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Public Device Record Key

c7a161a5-54bc-4f0e-98d0-f5cfb707953c

Public Version Date

March 10, 2022

Public Version Number

2

DI Record Publish Date

July 07, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-