Catalog Number

FM20001

Brand Name

ToeMobile™ Great Toe Endoprosthesis

Version/Model Number

Metatarsal 1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 16, 2020

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K072251

Product Code

LZJ

Product Code Name

Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained

Public Device Record Key

c49ee0fa-1cd1-4bd5-8c54-c4032fcc41c1

Public Version Date

February 21, 2022

Public Version Number

6

DI Record Publish Date

October 15, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-