Catalog Number

AL2-40-160

Brand Name

OrthoMedFlex, LLC

Version/Model Number

AL2-40-160

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

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

-

Product Code

LPH

Product Code Name

Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Public Device Record Key

b1c66cd5-baf6-4045-a847-b864fedc8936

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

April 25, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-