Catalog Number

OS900102-NS

Brand Name

OrthoSolutions 'System26' Bone Screws

Version/Model Number

OS900102-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

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

K163489

Product Code

HTY

Product Code Name

Pin, Fixation, Smooth

Public Device Record Key

26936d19-23af-42b0-bdb9-e46bdf7d0d97

Public Version Date

October 02, 2019

Public Version Number

1

DI Record Publish Date

September 24, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-