Catalog Number

1504.14.101

Brand Name

TEMA Elbow

Version/Model Number

1504.14.101

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

K181362

Product Code

JDB

Product Code Name

Prosthesis, Elbow, Semi-Constrained, Cemented

Public Device Record Key

47ea8599-92b7-405e-9e3a-5e56567821ea

Public Version Date

June 03, 2019

Public Version Number

1

DI Record Publish Date

May 24, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-