Catalog Number

BH400338

Brand Name

M2A - MODULAR HEAD HIP SYSTEM

Version/Model Number

BH400338

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

K061423

Product Code

KWA

Product Code Name

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

Public Device Record Key

6b4ad648-ac4b-4f38-9d73-c243ca7ddb3d

Public Version Date

September 09, 2020

Public Version Number

2

DI Record Publish Date

March 25, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-