Duns Number:015299627
Device Description: STRIDE Tibial Insert Implant SIZE B, 10 mm
Catalog Number
-
Brand Name
STRIDE Unicondylar Knee
Version/Model Number
110049
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 16, 2016
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
-
Product Code
HSX
Product Code Name
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Public Device Record Key
1e13cdac-898f-4e3b-99ad-bd41650f990a
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 24, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 56 |