Catalog Number

C-M113-1-300

Brand Name

Axel Pin Assembly Standard Elbow

Version/Model Number

C-M113-1-300

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

K980502,K980502,K980502

Product Code

JDC

Product Code Name

PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

Public Device Record Key

d2d655bc-aeff-4f51-a86d-2d3c458251d0

Public Version Date

March 31, 2022

Public Version Number

1

DI Record Publish Date

March 23, 2022

Package DI Number

37613327590051

Quantity per Package

1

Contains DI Package

07613327590050

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack