Catalog Number

-

Brand Name

PathLoc-SI Joint Fusion System

Version/Model Number

1023-8035S

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K181600

Product Code

OUR

Product Code Name

Sacroiliac Joint Fixation

Public Device Record Key

805dda69-2e5f-4776-a4a2-609d3f493195

Public Version Date

November 02, 2018

Public Version Number

1

DI Record Publish Date

October 02, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-