Duns Number:080506581
Device Description: S-ROM NOILES ROTATING HINGE TIBIAL PLATEAU ASSEMBLY WITH 2 HINGE BEARINGS 26mm SMALL
Catalog Number
621614
Brand Name
S-ROM NOILES
Version/Model Number
62-1614
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
K011810,K896048
Product Code
KRO
Product Code Name
PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
Public Device Record Key
b738db7f-703b-4889-9333-b74a3d158f2b
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2015
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 | 5254 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4003 |
| 3 | A medical device with high risk that requires premarket approval | 908 |