Duns Number:315675488
Device Description: Femoral Component - posterior stabilized
Catalog Number
318-413/02
Brand Name
Gemini SL
Version/Model Number
318-413/02
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
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
K182872
Product Code
JWH
Product Code Name
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Public Device Record Key
018c1457-5dd1-41f1-8c5a-baf60d45229c
Public Version Date
December 11, 2019
Public Version Number
2
DI Record Publish Date
April 17, 2019
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 | 154 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3922 |
| U | Unclassified | 42 |