Catalog Number

OS212100

Brand Name

ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS

Version/Model Number

OS212100

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

c82ce4c8-7d9f-43e3-bbb6-412ff3aaee53

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 23, 2017

Package DI Number

05055662922103

Quantity per Package

10

Contains DI Package

05055662922110

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Cardboard Box