Duns Number:808821883
Device Description: (Stainless Steel) Trial Neck 132degree,29.0mm
Catalog Number
1080-652
Brand Name
Cordera Hip System (Stainless Steel) Trial Neck 132degree,29.0mm
Version/Model Number
1080-652
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
-
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
K202484
Product Code
LPH
Product Code Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Public Device Record Key
5174395b-b0dd-476e-bdb3-1b9d71167e88
Public Version Date
March 15, 2022
Public Version Number
1
DI Record Publish Date
March 07, 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 | 109 |
2 | A medical device with a moderate to high risk that requires special controls. | 1451 |