Catalog Number

EPA0055CLA

Brand Name

FIXIT

Version/Model Number

FIXIT Threaded anchor system

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 09, 2020

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K170868

Product Code

MAI

Product Code Name

Fastener, Fixation, Biodegradable, Soft Tissue

Public Device Record Key

642d3ae2-e77d-4095-baae-20a00f5f99db

Public Version Date

January 31, 2022

Public Version Number

6

DI Record Publish Date

December 06, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-