Catalog Number

1201-0100

Brand Name

Solum IV Bone Void Filler

Version/Model Number

Solum IV - 10cc

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

K132470

Product Code

MQV

Product Code Name

Filler, Bone Void, Calcium Compound

Public Device Record Key

94600e00-20ef-478c-9015-3ec65511a238

Public Version Date

April 11, 2022

Public Version Number

5

DI Record Publish Date

September 20, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-