Catalog Number

A-2005

Brand Name

APTUS

Version/Model Number

A-2005

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

K193639

Product Code

HRS

Product Code Name

Plate, fixation, bone

Public Device Record Key

ff3063b0-4916-4e57-9476-3aea70b052ff

Public Version Date

June 01, 2020

Public Version Number

1

DI Record Publish Date

May 22, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-