Catalog Number

OS333517-X-RAY-TEMPLATEII

Brand Name

OXFORD ANKLE FUSION NAIL(AFN) SYSTEM

Version/Model Number

OS333517-X-RAY-TEMPLATEII

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K121575

Product Code

HSB

Product Code Name

Rod, Fixation, Intramedullary And Accessories

Public Device Record Key

3746891b-b1e4-4f6f-82ac-99b138608c6d

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

March 20, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-