Catalog Number

51-3045-045

Brand Name

Taurus Pedicle Screw System

Version/Model Number

B

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 05, 2018

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

-

Product Code

KWP

Product Code Name

Appliance, Fixation, Spinal Interlaminal

Public Device Record Key

0edd7c0b-f721-493f-90fa-e6d44594f6a8

Public Version Date

December 03, 2018

Public Version Number

4

DI Record Publish Date

December 29, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-