Catalog Number

T6216050

Brand Name

KangLi Pedicle Screw Spinal System

Version/Model Number

T6216050

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K140053

Product Code

MNH

Product Code Name

Orthosis, Spondylolisthesis Spinal Fixation

Public Device Record Key

d79828bc-8918-4d91-98b4-6960b4e0eb66

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

-