Catalog Number

OS900026-NS

Brand Name

OrthoSolutions 'System26' Bone Screws

Version/Model Number

OS900026-NS

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 12, 2021

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

21d783bb-ffbc-4753-8ec2-13abca386d9a

Public Version Date

March 15, 2021

Public Version Number

4

DI Record Publish Date

March 16, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-