Catalog Number

OS320049

Brand Name

ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS

Version/Model Number

OS320049

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

fbd9bab6-7090-4ce9-8404-538a407eddcb

Public Version Date

July 23, 2020

Public Version Number

5

DI Record Publish Date

February 19, 2016

Package DI Number

05055662932966

Quantity per Package

10

Contains DI Package

05055662932959

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Cardboard Box