Catalog Number

-

Brand Name

Zyfix Spinal Facet Screw System

Version/Model Number

X076-0038

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

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

K123932

Product Code

MRW

Product Code Name

SYSTEM, FACET SCREW SPINAL DEVICE

Public Device Record Key

ff2d480d-29fb-4a58-83e0-4a347b835572

Public Version Date

June 03, 2021

Public Version Number

6

DI Record Publish Date

August 28, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-