Catalog Number

M-2215-5032

Brand Name

STERIZO Total Hip System

Version/Model Number

Rev A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K143314

Product Code

LPH

Product Code Name

Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Public Device Record Key

b19a4468-4d47-42c0-80b9-df3b4541fb7b

Public Version Date

February 15, 2022

Public Version Number

1

DI Record Publish Date

February 07, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-