Catalog Number

OS435000

Brand Name

ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS

Version/Model Number

OS435000

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

K111678,K111678

Product Code

HRS

Product Code Name

Plate, Fixation, Bone

Public Device Record Key

886a9b39-d790-4f05-b95c-a479481fd4bc

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 16, 2016

Package DI Number

05055662917369

Quantity per Package

10

Contains DI Package

05055662917376

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Cardboard Box