Catalog Number

CTM000758-008 TI

Brand Name

RetroFix

Version/Model Number

80L:PROX5-40L:DIST4.5 TI

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

K200226

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Public Device Record Key

33c317ab-e54d-4e10-9d3d-303bfcd9a961

Public Version Date

December 31, 2020

Public Version Number

1

DI Record Publish Date

December 23, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-