Catalog Number

-

Brand Name

Kalitec Direct InSePtion MIS Fixation System

Version/Model Number

14-ILP-0010

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 20, 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

PEK

Product Code Name

Spinous Process Plate

Public Device Record Key

d0fa9de0-1b5c-4bd9-b817-534389f3fc79

Public Version Date

April 23, 2019

Public Version Number

4

DI Record Publish Date

March 31, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-