Duns Number:295437313
Device Description: Cormet resurfacing head - 44mm size 4 cemented
Catalog Number
-
Brand Name
Cormet
Version/Model Number
179.044
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 15, 2014
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K994153,P050016
Product Code
KXA
Product Code Name
Prosthesis, Hip, Femoral, Resurfacing
Public Device Record Key
ab6f8e74-32f4-4076-88aa-b78feda22016
Public Version Date
November 08, 2019
Public Version Number
5
DI Record Publish Date
October 14, 2014
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3697 |
| 3 | A medical device with high risk that requires premarket approval | 21 |