Catalog Number

1067718-45

Brand Name

Biomet OrthoPak Non-invasive Bone Growth Stimulator System

Version/Model Number

1067718-45

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

P850022

Product Code

LOF

Product Code Name

Stimulator, Bone Growth, Non-Invasive

Public Device Record Key

e20ae408-af2b-4e85-8732-c0b2c5e9a81f

Public Version Date

March 10, 2022

Public Version Number

2

DI Record Publish Date

February 28, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-