Catalog Number

-

Brand Name

SI-BONE

Version/Model Number

RETIRED

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 05, 2015

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K080398

Product Code

OUR

Product Code Name

Sacroiliac joint fixation

Public Device Record Key

83892031-8e56-43b3-9372-a7978342a25d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 15, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-