Catalog Number

-

Brand Name

Additive Orthopaedics Hammertoe System

Version/Model Number

AOHT3019i

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

K160264

Product Code

HTY

Product Code Name

Pin, Fixation, Smooth

Public Device Record Key

2d136412-75f1-450f-be62-ca36e52dbb0c

Public Version Date

July 24, 2019

Public Version Number

1

DI Record Publish Date

July 16, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-