Catalog Number

GB03005

Brand Name

OsteoBridge™ IDSF Diaphysis Spacer

Version/Model Number

30 50

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 01, 2016

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

K051965

Product Code

HSB

Product Code Name

Rod, Fixation, Intramedullary And Accessories

Public Device Record Key

2d3a0867-68e0-44ea-a734-a9c8c4546737

Public Version Date

August 01, 2018

Public Version Number

4

DI Record Publish Date

October 15, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-