RIBFIX BLU SYSTEM - BIOMET MICROFIXATION, INC

Duns Number:046189866

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


More Product Details

Catalog Number

76-2512

Brand Name

RIBFIX BLU SYSTEM

Version/Model Number

76-2512

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 27, 2020

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

K151173,K152253,K162974

Product Code Details

Product Code

HRS

Product Code Name

Plate, fixation, bone

Device Record Status

Public Device Record Key

6dfd32db-ea2e-42a7-aca8-32cc8780bb4d

Public Version Date

July 27, 2020

Public Version Number

4

DI Record Publish Date

October 11, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIOMET MICROFIXATION, INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1783
2 A medical device with a moderate to high risk that requires special controls. 11874
3 A medical device with high risk that requires premarket approval 34