Duns Number:989365556
Device Description: EMPHASYS FEMORAL STEM COLLARLESS HIGH OFFSET HA COATED CEMENTLESS 5 HO
Catalog Number
474205100
Brand Name
EMPHASYS
Version/Model Number
4742-05-100
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K211657
Product Code
KWL
Product Code Name
Prosthesis, hip, hemi-, femoral, metal
Public Device Record Key
b5e0eb84-39db-4f36-b512-6e03a3458b44
Public Version Date
September 06, 2021
Public Version Number
1
DI Record Publish Date
August 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 | 3549 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2188 |
| 3 | A medical device with high risk that requires premarket approval | 418 |