Catalog Number

2031004

Brand Name

K2™ Hemi Toe Implant System

Version/Model Number

2031004

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

-

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

K023770

Product Code

KWD

Product Code Name

PROSTHESIS, TOE, HEMI-, PHALANGEAL

Public Device Record Key

6f5ca793-9eac-4367-a19b-b168bdc028ac

Public Version Date

February 21, 2022

Public Version Number

3

DI Record Publish Date

April 10, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-