Catalog Number

-

Brand Name

ANAXTM5.5 Spinal System

Version/Model Number

SF5095CSM

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

K162189

Product Code

MNI

Product Code Name

ORTHOSIS, SPINAL PEDICLE FIXATION

Public Device Record Key

7773649c-1353-439a-aa7b-cfce24737717

Public Version Date

June 17, 2019

Public Version Number

4

DI Record Publish Date

November 22, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-