Catalog Number

ACO Planner

Brand Name

ACO Planner

Version/Model Number

ACO Planner

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 08, 2019

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K150780

Product Code

PLW

Product Code Name

Acetabular Cup Orientation System

Public Device Record Key

b203782d-8f3b-4e82-93cb-a309fb4aec7f

Public Version Date

February 21, 2022

Public Version Number

5

DI Record Publish Date

February 10, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-