Duns Number:315675488
Device Description: Femoral Cutting Block, CCK, 4-in-1 Cut, Size 7
Catalog Number
881-115/70
Brand Name
LinkSymphoKnee
Version/Model Number
881-115/70
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
K202924
Product Code
HRY
Product Code Name
PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
Public Device Record Key
289f2369-e6dc-4c47-85bf-f8225ee4f1b3
Public Version Date
October 15, 2021
Public Version Number
1
DI Record Publish Date
October 07, 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 | 154 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3922 |
| U | Unclassified | 42 |