Catalog Number

-

Brand Name

Pediatric Long Bone Combo K-Wire System

Version/Model Number

KIT-KWI-LBONE

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 16, 2020

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

K173013

Product Code

HTY

Product Code Name

Pin, Fixation, Smooth

Public Device Record Key

16c37fb4-8e67-4db6-a9af-b3415d3e4a74

Public Version Date

March 25, 2021

Public Version Number

3

DI Record Publish Date

March 19, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-