Catalog Number

-

Brand Name

SI-LUTION Sacroiliac Joint Fusion System

Version/Model Number

C614-9545

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K210402

Product Code

OUR

Product Code Name

Sacroiliac Joint Fixation

Public Device Record Key

0ad6237e-b398-44b2-91b9-da46845eae06

Public Version Date

September 27, 2021

Public Version Number

1

DI Record Publish Date

September 17, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-