Catalog Number

OS333522

Brand Name

OXFORD ANKLE FUSION NAIL(AFN) SYSTEM

Version/Model Number

OS333522

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

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Public Device Record Key

d78bc2ec-2499-4c89-80af-c9ebf14e3fe0

Public Version Date

April 06, 2020

Public Version Number

5

DI Record Publish Date

July 21, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-