Duns Number:270195749
Device Description: Reusable instrument for Total Knee Arthroplasty
Catalog Number
KNI010
Brand Name
Control Tool
Version/Model Number
Knee+
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OLO
Product Code Name
Orthopedic Stereotaxic Instrument
Public Device Record Key
0ae4cec9-182a-47b9-9dc4-b5e3d887c5d3
Public Version Date
October 18, 2021
Public Version Number
1
DI Record Publish Date
October 08, 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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 17 |