Catalog Number

588.6450

Brand Name

TaperFit Cemented Hip System

Version/Model Number

588.6450

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

-

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

K142761

Product Code

JDG

Product Code Name

Prosthesis, hip, femoral component, cemented, metal

Public Device Record Key

1593ca49-6a01-4515-b902-8b55a8735d57

Public Version Date

September 21, 2018

Public Version Number

1

DI Record Publish Date

August 21, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-