Catalog Number

-

Brand Name

Proform Hip System

Version/Model Number

SC2543-6668

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 25, 2019

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

-

Product Code

JDO

Product Code Name

Device, Fixation, Proximal Femoral, Implant

Public Device Record Key

713a9e1d-4e48-461d-84ca-d9b1b1a980a1

Public Version Date

December 11, 2020

Public Version Number

4

DI Record Publish Date

August 05, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-