Catalog Number

PT-104062

Brand Name

REGENEREX RINGLOC + HIP SYSTEM

Version/Model Number

PT-104062

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

K070369

Product Code

JDG

Product Code Name

Prosthesis, hip, femoral component, cemented, metal

Public Device Record Key

959ceef4-75fb-4424-a140-3ba0f4894211

Public Version Date

September 09, 2020

Public Version Number

4

DI Record Publish Date

October 24, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-