Catalog Number

-

Brand Name

Polarfix™ Facet Screw System

Version/Model Number

FSA5540

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

K173198

Product Code

MRW

Product Code Name

SYSTEM, FACET SCREW SPINAL DEVICE

Public Device Record Key

bdea9db6-488b-4d96-afd0-51bb9e1e3c96

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

May 17, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-