Catalog Number

165.010

Brand Name

Corifix Ligament Anchor Screw

Version/Model Number

165.010

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K973005

Product Code

HWC

Product Code Name

Screw, fixation, bone

Public Device Record Key

94a7ed25-985a-49cb-a0d7-ca63b35a93a8

Public Version Date

January 08, 2019

Public Version Number

4

DI Record Publish Date

August 17, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-