Duns Number:080068420
Device Description: Distal Fibula Plate Standard Syndesmosis Screw Holes, 7-Hole
Catalog Number
-
Brand Name
Distal Fibula Plating System
Version/Model Number
12660107
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
Product Code
HRS
Product Code Name
Plate, fixation, bone
Public Device Record Key
d8e1b1d5-fdaa-4958-944a-713905f55e8f
Public Version Date
January 18, 2022
Public Version Number
1
DI Record Publish Date
January 10, 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 | 65 |
2 | A medical device with a moderate to high risk that requires special controls. | 626 |