Duns Number:058864308
Device Description: CrossRoads™ Bone Screw System is used for fracture repair and fixation, osteotomy, joint f CrossRoads™ Bone Screw System is used for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the bone screw.
Catalog Number
1427-2710
Brand Name
CrossRoads™ Bone Screw
Version/Model Number
Snap-Off
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
K143039
Product Code
HWC
Product Code Name
Screw, Fixation, Bone
Public Device Record Key
b411fed0-cc8d-443d-b8ee-4a11b9b9e6a9
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 12, 2016
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 | 59 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 713 |