Duns Number:109903521
Device Description: REDAPT ANTEVERTED CEMENTED SCREW IN TRIAL LINER 40MM X REDAPT ANTEVERTED CEMENTED SCREW IN TRIAL LINER 40MM X 64MM
Catalog Number
71354626
Brand Name
REDAPT
Version/Model Number
71354626
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
K160923
Product Code
JDI
Product Code Name
Prosthesis, hip, semi-constrained, metal/polymer, cemented
Public Device Record Key
f37db007-22e0-4b7c-aa02-dd7ea4b29d04
Public Version Date
December 21, 2020
Public Version Number
7
DI Record Publish Date
December 07, 2016
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 | 10651 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
| 3 | A medical device with high risk that requires premarket approval | 351 |