Duns Number:989365556
Device Description: SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL INSERT FIXED BEARING UNICONDYLAR SIZE 2 RM/LL 9 SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL INSERT FIXED BEARING UNICONDYLAR SIZE 2 RM/LL 9MM
Catalog Number
102456209
Brand Name
SIGMA
Version/Model Number
1024-56-209
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
K193549
Product Code
HRY
Product Code Name
PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
Public Device Record Key
ff39fe85-ea2a-4c2f-8e3e-4f2eb169eab8
Public Version Date
May 03, 2021
Public Version Number
1
DI Record Publish Date
April 23, 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 |