Catalog Number

NJ314K

Brand Name

Excia®

Version/Model Number

NJ314K

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 14, 2022

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

-

Product Code

JDI

Product Code Name

Prosthesis, hip, semi-constrained, metal/polymer, cemented

Public Device Record Key

2d664c78-7d4f-4c14-892f-9169153f8197

Public Version Date

June 16, 2022

Public Version Number

3

DI Record Publish Date

September 24, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-