Catalog Number

GB03406

Brand Name

OsteoBridge™ IDSF Diaphysis Spacer

Version/Model Number

34 60

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 11, 2020

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

K142451

Product Code

HSB

Product Code Name

Rod, Fixation, Intramedullary And Accessories

Public Device Record Key

4f591bbf-a3c2-4479-b5b9-37728a93e30a

Public Version Date

February 12, 2020

Public Version Number

5

DI Record Publish Date

October 15, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-