Duns Number:022576742
Catalog Number
-
Brand Name
Foot Plate Locking Screw
Version/Model Number
FPS3528
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
K143365
Product Code
HRS
Product Code Name
Plate, Fixation, Bone
Public Device Record Key
9ee20442-a0b8-4e97-ad05-b888ef6ac21e
Public Version Date
November 23, 2021
Public Version Number
4
DI Record Publish Date
February 08, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 884 |