Duns Number:951561048
Device Description: 5.0mm titanium cannulated cortex locking screw 46mm
Catalog Number
171.46
Brand Name
Traufix osteosynthesis, osteotomy, and arthrodesis devices
Version/Model Number
171.46
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
K201510
Product Code
HWC
Product Code Name
Screw, Fixation, Bone
Public Device Record Key
a0334cc4-5d2d-4984-8e8b-cb4c5b47d3c3
Public Version Date
October 14, 2022
Public Version Number
2
DI Record Publish Date
September 24, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 512 |