Duns Number:942377524
Device Description: The Viper Variable Angle Locking Technology (VALT) titanium screw, which is placed distall The Viper Variable Angle Locking Technology (VALT) titanium screw, which is placed distally.
Catalog Number
27142718
Brand Name
Viper® Distal Volar Radius Plating System
Version/Model Number
27142718
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
K041461
Product Code
HRS
Product Code Name
Plate, Fixation, Bone
Public Device Record Key
f66e07c0-e4f2-4ba3-b6eb-3bd9ee5138b8
Public Version Date
March 08, 2021
Public Version Number
5
DI Record Publish Date
October 09, 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 | 1909 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1404 |
| 3 | A medical device with high risk that requires premarket approval | 12 |
| U | Unclassified | 15 |