Catalog Number

100-0610-009

Brand Name

Distal fibula plates, left 151mm/9 holes

Version/Model Number

100-0610-009

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

-

Product Code

HRS

Product Code Name

Plate, fixation, bone

Public Device Record Key

e2000ba6-e16c-4b48-b32c-0355f0a95afe

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 01, 2016

Package DI Number

EMAH10006100091

Quantity per Package

1

Contains DI Package

EMAH10006100090

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-