Duns Number:969820245
Device Description: The DTRAX Bone Screw is a single-use implant made of titanium alloy and used in bone recon The DTRAX Bone Screw is a single-use implant made of titanium alloy and used in bone reconstruction, osteotomy, arthrodesis, join fusion, fracture repair and fixation appropriate for the size of the device.
Catalog Number
-
Brand Name
DTRAX Bone Screw
Version/Model Number
PD-32-301
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 09, 2019
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
K121713
Product Code
HWC
Product Code Name
Screw, Fixation, Bone
Public Device Record Key
2e336266-a8ff-4d76-9ca0-f4ae8d9e1950
Public Version Date
April 10, 2019
Public Version Number
5
DI Record Publish Date
September 15, 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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 22 |