Duns Number:989365556
Device Description: ATTUNE KNEE SYSTEM TIBIAL INSERT TRIAL TRAY FIXED BEARING MEDIAL STABILIZED RIGHT 1-2, 5-1 ATTUNE KNEE SYSTEM TIBIAL INSERT TRIAL TRAY FIXED BEARING MEDIAL STABILIZED RIGHT 1-2, 5-16mm 3-10, 14-16mm
Catalog Number
254700004
Brand Name
ATTUNE
Version/Model Number
2547-00-004
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
-
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
FSM
Product Code Name
TRAY, SURGICAL, INSTRUMENT
Public Device Record Key
8eb1d4d7-9f9a-41a7-b511-1b4da962ce12
Public Version Date
September 16, 2022
Public Version Number
2
DI Record Publish Date
December 03, 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 | 3549 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2188 |
| 3 | A medical device with high risk that requires premarket approval | 418 |