Duns Number:080254074
Device Description: ELEOS™ SEGMENTAL STEM, CANAL FILLING STRAIGHT, SLOTTED, SPLINED, 2/3 PLASMA, 25MM COLLAR ELEOS™ SEGMENTAL STEM, CANAL FILLING STRAIGHT, SLOTTED, SPLINED, 2/3 PLASMA, 25MM COLLAR 14MM X 152MM
Catalog Number
SPSE0003E
Brand Name
ELEOS™
Version/Model Number
SPSE0003E
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
6c974993-ce57-4492-841c-29b6a3591175
Public Version Date
March 11, 2019
Public Version Number
4
DI Record Publish Date
April 03, 2017
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 |