Duns Number:080254074
Device Description: ELEOS™ Tibial Baseplate Tapered Screw
Catalog Number
TB-TSCRW-01N
Brand Name
ELEOS™ Limb Salvage System
Version/Model Number
TB-TSCRW-01N
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
Product Code
KRO
Product Code Name
PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
Public Device Record Key
086478ec-7e84-4e86-8450-e19636dc9319
Public Version Date
October 06, 2021
Public Version Number
1
DI Record Publish Date
September 28, 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 | 378 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 231 |
| 3 | A medical device with high risk that requires premarket approval | 4 |