Corin Taper-Fit Total Hip System - ALLEN KEY - CORIN LTD

Duns Number:295437313

Device Description: ALLEN KEY

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More Product Details

Catalog Number

11903

Brand Name

Corin Taper-Fit Total Hip System

Version/Model Number

11903

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K992234

Product Code Details

Product Code

JDG

Product Code Name

Prosthesis, hip, femoral component, cemented, metal

Device Record Status

Public Device Record Key

bf885e55-83d0-4bfb-a4ff-f2fe9b7ec6d4

Public Version Date

October 05, 2018

Public Version Number

5

DI Record Publish Date

August 17, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CORIN LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 3697
3 A medical device with high risk that requires premarket approval 21