Catalog Number

HTR-04-164605

Brand Name

ORION WEDGE

Version/Model Number

HTR-04-164605

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

K150394

Product Code

PLF

Product Code Name

Bone Wedge

Public Device Record Key

95adcd7b-4a46-400b-b61e-8ba334a7b489

Public Version Date

June 08, 2021

Public Version Number

4

DI Record Publish Date

June 30, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-