Duns Number:989365556
Device Description: CORAIL HIP SYSTEM CEMENTLESS FEMORAL STEM 12/14 AMT 135 DEGREES KHO SIZE 15 HA COATED HIGH CORAIL HIP SYSTEM CEMENTLESS FEMORAL STEM 12/14 AMT 135 DEGREES KHO SIZE 15 HA COATED HIGH OFFSET NO COLLAR
Catalog Number
L20315
Brand Name
CORAIL
Version/Model Number
L20315
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
K192946,K190344,K070554,K042992
Product Code
KWA
Product Code Name
Prosthesis, hip, semi-constrained (metal uncemented acetabular component)
Public Device Record Key
5a3bee38-a05b-4e6c-a5d8-b8eed5635885
Public Version Date
September 18, 2020
Public Version Number
7
DI Record Publish Date
March 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 | 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 |