Duns Number:157565946
Device Description: Alteon Highly Polished Femoral Stem
Catalog Number
190-61-09
Brand Name
Alteon
Version/Model Number
190-61-09
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"
Yes
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
K182462
Product Code
KWL
Product Code Name
Prosthesis, Hip, Hemi-, Femoral, Metal
Public Device Record Key
ab745900-bf66-4042-9148-1f7f122a9f20
Public Version Date
January 03, 2019
Public Version Number
1
DI Record Publish Date
December 03, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3717 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7206 |
| 3 | A medical device with high risk that requires premarket approval | 28 |