Catalog Number

A-8416.85/1

Brand Name

APTUS

Version/Model Number

A-8416.85/1

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

K202589

Product Code

HWC

Product Code Name

Screw, fixation, bone

Public Device Record Key

365af50e-d76d-4c4b-b2ce-264855967117

Public Version Date

November 23, 2020

Public Version Number

1

DI Record Publish Date

November 14, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-