LEGION - OXINIUM LEGION HK THREADED AXLE - Smith & Nephew, Inc.

Duns Number:109903521

Device Description: OXINIUM LEGION HK THREADED AXLE SIZE 3 FEMUR

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More Product Details

Catalog Number

XK000644-3

Brand Name

LEGION

Version/Model Number

XK000644-3

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

K151118

Product Code Details

Product Code

KRO

Product Code Name

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

Device Record Status

Public Device Record Key

1c58ca82-ba36-404e-aa37-a4743e91aeba

Public Version Date

October 18, 2018

Public Version Number

1

DI Record Publish Date

September 17, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SMITH & NEPHEW, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10651
2 A medical device with a moderate to high risk that requires special controls. 35590
3 A medical device with high risk that requires premarket approval 351