Catalog Number

-

Brand Name

AFX

Version/Model Number

P07 N1206

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

-

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

K181113

Product Code

HRS

Product Code Name

Plate, Fixation, Bone

Public Device Record Key

8ac4cbdf-98ef-425a-b59e-d6454b4d4f57

Public Version Date

April 21, 2021

Public Version Number

3

DI Record Publish Date

October 22, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-