Catalog Number

OS900055-NS

Brand Name

OrthoSolutions 'System26' Bone Screws

Version/Model Number

OS900055-NS

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K163489

Product Code

HXX

Product Code Name

Screwdriver

Public Device Record Key

63c71a9b-f5e6-4b1d-8677-aca2cbefeafa

Public Version Date

October 05, 2018

Public Version Number

5

DI Record Publish Date

March 16, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-