Catalog Number

CAT-02

Brand Name

7.5x40mm SIJ Implant

Version/Model Number

CAT-02

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

c5cbd83d-c71a-47f9-b826-14321b7d1721

Public Version Date

December 17, 2021

Public Version Number

4

DI Record Publish Date

May 23, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-