Catalog Number

-

Brand Name

True Spinal Fixation System

Version/Model Number

105-9-302-530

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

-

Product Code

NKB

Product Code Name

Thoracolumbosacral Pedicle Screw System

Public Device Record Key

02024be6-f550-4e3a-b48f-30e0545097c8

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 26, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-