Catalog Number

40308-28

Brand Name

Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)

Version/Model Number

40308-28

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 17, 2021

Issuing Agency

In HIBCC

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

K180818

Product Code

OUR

Product Code Name

Sacroiliac Joint Fixation

Public Device Record Key

66dea308-d530-4203-9e9c-0027e8879d32

Public Version Date

December 17, 2021

Public Version Number

4

DI Record Publish Date

June 12, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-