Catalog Number

OS913085-NS

Brand Name

OrthoSolutions 'System26' Bone Screws

Version/Model Number

OS913085-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

HWC

Product Code Name

Screw, Fixation, Bone

Public Device Record Key

3e9d9545-31db-4315-af6a-1f0a9ca59ce6

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 13, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-