Duns Number:034442726
Device Description: Kratos Hip Stem, Standard Offset Collarless, Cementless - Size 18, Ti6AI4V Alloy with HA C Kratos Hip Stem, Standard Offset Collarless, Cementless - Size 18, Ti6AI4V Alloy with HA Coating
Catalog Number
AS-618
Brand Name
OrthoMedFlex
Version/Model Number
AS-618
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MEH
Product Code Name
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
Public Device Record Key
47657f91-111f-4f39-9e5d-5e0bcc5a4b8b
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 09, 2015
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 | 371 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 435 |