Catalog Number

COM6010R35

Brand Name

LIGAFIX

Version/Model Number

LIGAFIX 60 round head

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

K122228

Product Code

MAI

Product Code Name

Fastener, Fixation, Biodegradable, Soft Tissue

Public Device Record Key

6418dc8e-9abe-481a-b310-bd88d6871479

Public Version Date

July 18, 2022

Public Version Number

7

DI Record Publish Date

September 23, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-