Catalog Number

00-7805-021-01

Brand Name

Kinectiv®

Version/Model Number

00-7805-021-01

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

K110836

Product Code

KWZ

Product Code Name

Prosthesis, hip, constrained, cemented or uncemented, metal/polymer

Public Device Record Key

3980c0c5-1632-4d88-a93c-1dcf4145107a

Public Version Date

November 19, 2020

Public Version Number

6

DI Record Publish Date

August 30, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-