Catalog Number

1125-0004

Brand Name

NovoHip Total Hip System

Version/Model Number

1125-0004

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

K132158

Product Code

LPH

Product Code Name

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

Public Device Record Key

b57b4e7a-6a00-4577-a983-80e8b88c4af4

Public Version Date

September 02, 2021

Public Version Number

1

DI Record Publish Date

August 25, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-