Catalog Number

US257866

Brand Name

M2a Magnum™ Hip System

Version/Model Number

US257866

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

K062995,K101336

Product Code

KWA

Product Code Name

Prosthesis, hip, semi-constrained (metal uncemented acetabular component)

Public Device Record Key

c9397516-718c-499b-b5d6-7a27e9c417c2

Public Version Date

September 09, 2020

Public Version Number

6

DI Record Publish Date

October 06, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-