Kinemax - Extra Small Kinemax Tibial Insert - Howmedica Osteonics Corp.

Duns Number:058311945

Device Description: Extra Small Kinemax Tibial Insert

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

C-M109-7-002

Brand Name

Kinemax

Version/Model Number

C-M109-7-002

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

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

K871772

Product Code Details

Product Code

JWH

Product Code Name

PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Device Record Status

Public Device Record Key

19fa2904-99a7-41fa-8669-ea9d09b508ce

Public Version Date

May 21, 2019

Public Version Number

1

DI Record Publish Date

May 13, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HOWMEDICA OSTEONICS CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5091
2 A medical device with a moderate to high risk that requires special controls. 10216
3 A medical device with high risk that requires premarket approval 32