Catalog Number

-

Brand Name

Orthex Half Pin

Version/Model Number

HPP40-150-15B

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

K132820

Product Code

JDW

Product Code Name

Pin, Fixation, Threaded

Public Device Record Key

59e44951-2afa-48f5-b7e8-0ca436ce779f

Public Version Date

May 25, 2020

Public Version Number

5

DI Record Publish Date

August 22, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-