Duns Number:080437990
Device Description: Origin Stem, Coxa Vara Size 18
Catalog Number
-
Brand Name
Paxeon Origin Coxa Vara Hip Stem
Version/Model Number
PR111-18-1804
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
K161155
Product Code
KWZ
Product Code Name
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Public Device Record Key
8099f38c-08cd-4021-a83d-750e52d0ac30
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 14, 2016
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. | 205 |