ANTHEM - ANTHEM Ti Lateral Narrow Distal Femur Plate, - GLOBUS MEDICAL, INC.

Duns Number:139105691

Device Description: ANTHEM Ti Lateral Narrow Distal Femur Plate, Left, 7 Hole, 202mm

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


More Product Details

Catalog Number

-

Brand Name

ANTHEM

Version/Model Number

1195.1207

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K213591

Product Code Details

Product Code

HRS

Product Code Name

Plate, fixation, bone

Device Record Status

Public Device Record Key

4e207716-ac8b-4777-8af2-75510cb09f34

Public Version Date

May 09, 2022

Public Version Number

1

DI Record Publish Date

April 29, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GLOBUS MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4975
2 A medical device with a moderate to high risk that requires special controls. 34645
3 A medical device with high risk that requires premarket approval 57
U Unclassified 232