Catalog Number

-

Brand Name

TowerLOX EXT Overflow Tray Assembly

Version/Model Number

16301-7021

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

725d0b8f-5b04-452d-8411-57a2adae0ea6

Public Version Date

December 17, 2018

Public Version Number

1

DI Record Publish Date

November 15, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-