Catalog Number

SPI-040322

Brand Name

Alteon

Version/Model Number

SPI-040322

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

-

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

K140674,K162732,K182462

Product Code

KWZ

Product Code Name

Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer

Public Device Record Key

bdf730ff-849a-4d1c-83ab-aa07d315fbdf

Public Version Date

January 21, 2022

Public Version Number

1

DI Record Publish Date

January 13, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-