Catalog Number

-

Brand Name

TITANIUM PISTON

Version/Model Number

413-425

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K060518

Product Code

ETB

Product Code Name

PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT

Public Device Record Key

457211c7-56b1-424c-bf23-f7eb6f821543

Public Version Date

June 22, 2020

Public Version Number

5

DI Record Publish Date

February 18, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-