Catalog Number

55000063

Brand Name

FIBERGRAFT BG Matrix

Version/Model Number

5500-0063

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K171284

Product Code

MQV

Product Code Name

Filler, Bone Void, Calcium Compound

Public Device Record Key

7c43c321-4a2e-4e3e-aa4b-97eb17c9a1d1

Public Version Date

April 14, 2021

Public Version Number

6

DI Record Publish Date

December 07, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-