Catalog Number

OS323023

Brand Name

ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS

Version/Model Number

OS323023

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

K110895,K110895

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Public Device Record Key

6f53d652-cd33-439c-ba96-734892063d19

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 02, 2016

Package DI Number

05055662934793

Quantity per Package

10

Contains DI Package

05055662934809

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Cardboard Box