Catalog Number

58-0446

Brand Name

Facet Fixation

Version/Model Number

58-0446

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

K132859

Product Code

MRW

Product Code Name

SYSTEM, FACET SCREW SPINAL DEVICE

Public Device Record Key

d98c3dda-05fd-480a-aabd-a2ec70a043f9

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

February 04, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-