Duns Number:058864308
Device Description: The CrossTie™ Intraosseous Fixation System is used to aid in the fixation of fractures, fu The CrossTie™ Intraosseous Fixation System is used to aid in the fixation of fractures, fusions, and osteotomies of the toes, including hammertoe, claw toe, mallet toe and inter-digital fusions.
Catalog Number
-
Brand Name
CrossTIE™
Version/Model Number
1443-2500
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
-
Product Code
HWC
Product Code Name
Screw, Fixation, Bone
Public Device Record Key
031cf0fd-63de-4f3f-ba15-224517e25b7a
Public Version Date
April 23, 2019
Public Version Number
5
DI Record Publish Date
September 10, 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 | 59 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 713 |