Duns Number:808821883
Device Description: Triathlon AS-1 PS Surgical Instruments, CS insert, cemented, ream, sizes 0-8 Right and Le Triathlon AS-1 PS Surgical Instruments, CS insert, cemented, ream, sizes 0-8 Right and Left
Catalog Number
6556-C-009
Brand Name
Triathlon AS-1 PS Ream CS Insert Cemented Instrumentation Kit
Version/Model Number
6556C00901
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K203421
Product Code
JWH
Product Code Name
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Public Device Record Key
52b81c2f-d098-4c7c-913e-f461e5f2a688
Public Version Date
May 10, 2021
Public Version Number
1
DI Record Publish Date
April 30, 2021
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 | 109 |
2 | A medical device with a moderate to high risk that requires special controls. | 1451 |