Catalog Number

T5815540

Brand Name

KangLi Pedicle Screw Spinal System

Version/Model Number

T5815540

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 08, 2016

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K142290

Product Code

MNH

Product Code Name

Orthosis, Spondylolisthesis Spinal Fixation

Public Device Record Key

d9ab2dd2-f6a1-4f0e-9fd2-cdbf9b4a9d53

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 03, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-