Catalog Number

FO-2004-16

Brand Name

Orbitum Staple System

Version/Model Number

Rev A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K173693

Product Code

JDR

Product Code Name

Staple, Fixation, Bone

Public Device Record Key

b1136593-c9d2-4668-9af9-37c3bbe200a9

Public Version Date

April 26, 2021

Public Version Number

1

DI Record Publish Date

April 16, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-