Catalog Number

OS445100

Brand Name

ORTHO SOLUTIONS TRAUMA PLATES FOR OSTEOSYSNTHESIS

Version/Model Number

OS445100

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

K120360,K120360

Product Code

HRS

Product Code Name

Plate, Fixation, Bone

Public Device Record Key

74869991-5bc5-468c-ba6f-7e9798334fd3

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 18, 2016

Package DI Number

05055662913804

Quantity per Package

5

Contains DI Package

05055662913811

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Cardboard Box