Catalog Number

-

Brand Name

FairFix Adjustable Button System

Version/Model Number

05.05.0091

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K203259

Product Code

MBI

Product Code Name

Fastener, Fixation, Nondegradable, Soft Tissue

Public Device Record Key

5a2d7c67-08be-477e-9a9c-5166c425ebc9

Public Version Date

April 06, 2021

Public Version Number

1

DI Record Publish Date

March 29, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-