Duns Number:080254074
Device Description: ELEOS SEGMENTAL STEM, CANAL FILLING, STRAIGHT, SPLINED, FULL PLASMA, 36MM COLLAR, 19MM X 1 ELEOS SEGMENTAL STEM, CANAL FILLING, STRAIGHT, SPLINED, FULL PLASMA, 36MM COLLAR, 19MM X 120MM
Catalog Number
FS-19120-03M
Brand Name
ELEOS Limb Salvage System
Version/Model Number
FS-19120-03M
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
K161520
Product Code
JDI
Product Code Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Public Device Record Key
3948b55c-6a62-44ae-80db-ea229d4d8068
Public Version Date
May 24, 2022
Public Version Number
2
DI Record Publish Date
March 11, 2022
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 |