Catalog Number

50604-15

Brand Name

Osseofit™ Porous Tissue Matrix

Version/Model Number

50604-15

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 30, 2019

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

K060917

Product Code

MQV

Product Code Name

Filler, Bone Void, Calcium Compound

Public Device Record Key

aabd7a4f-ed8e-4426-8242-6237c9a41cee

Public Version Date

October 01, 2019

Public Version Number

5

DI Record Publish Date

September 01, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-