Duracon - Symmetric Patella - Howmedica Osteonics Corp.

Duns Number:058311945

Device Description: Symmetric Patella

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More Product Details

Catalog Number

6642-2-600

Brand Name

Duracon

Version/Model Number

6642-2-600

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

K052917,K961483

Product Code Details

Product Code

HRY

Product Code Name

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

Device Record Status

Public Device Record Key

108acba9-cf7b-49ea-8b44-a06ad0f4113a

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2015

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