Catalog Number

OS900022-NS

Brand Name

OrthoSolutions 'System26' Bone Screws

Version/Model Number

OS900022-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

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Public Device Record Key

38d71a49-09b9-49a4-8ab7-56b4d771b8e5

Public Version Date

August 09, 2018

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

-