Catalog Number

323.1004

Brand Name

AdvantageRib

Version/Model Number

323.1004

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

K141241

Product Code

HRS

Product Code Name

Plate, Fixation, Bone

Public Device Record Key

5358dc5b-744f-48e5-b798-28b2064232e4

Public Version Date

November 05, 2018

Public Version Number

1

DI Record Publish Date

October 03, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-