Duns Number:431406875
Device Description: Transfixing bone screw ø6mm L240mm.Material: titanium alloy Ti6Al4V ELI (ASTM F136).
Catalog Number
DF416240
Brand Name
DOLPHIX
Version/Model Number
Transfixing bone screw ø6mm L240mm
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 01, 2018
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
K132363
Product Code
JDW
Product Code Name
Pin, Fixation, Threaded
Public Device Record Key
5c4c4a0d-334b-4014-9a81-80b150c152f7
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 21, 2015
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 | 112 |
2 | A medical device with a moderate to high risk that requires special controls. | 1181 |