Catalog Number

PK-KWELB

Brand Name

WishBone K-Wire System

Version/Model Number

PK-KWELB

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"

Yes

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

5a159fd9-981f-4057-bc6f-ff57318fce59

Public Version Date

January 12, 2022

Public Version Number

2

DI Record Publish Date

December 02, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-