Catalog Number

US157860

Brand Name

M2a Magnum™ Hip System

Version/Model Number

US157860

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K101336,K042037

Product Code

KWA

Product Code Name

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

Public Device Record Key

965b5abc-2ea0-4fa5-896b-4614aea7bbaa

Public Version Date

September 09, 2020

Public Version Number

5

DI Record Publish Date

October 06, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-