Catalog Number

-

Brand Name

Silex Sacroiliac Joint Fusion System

Version/Model Number

C079-0263

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

-

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

K140079,K140079

Product Code

FZX

Product Code Name

Guide, Surgical, Instrument

Public Device Record Key

00186787-54eb-4ef7-a1b1-85a7fe1f1393

Public Version Date

June 03, 2022

Public Version Number

1

DI Record Publish Date

May 26, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-