Duns Number:942377524
Device Description: Cannulated screw is a machined, metallic screw that is manufactured from stainless steel a Cannulated screw is a machined, metallic screw that is manufactured from stainless steel and titanium with a cannulation that is self-drilling and self-tapping. The CAPTURE High-Torque Screw is intended for fixation of the pelvis and illiosacral join, as well as fixations of fractures and osteotomies in long and small bones, including those in the foot, patella, ankle, wrist, and elbow. Intended for use correction Arthrodesis of the foot, wrist and elbow.
Catalog Number
CSS50000052540T
Brand Name
CAPTURE™ High Torque Screw System
Version/Model Number
CSS50000052540T
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
K092440
Product Code
HWC
Product Code Name
Screw, fixation, bone
Public Device Record Key
6137a6f9-fe78-401f-9c2f-5ede0d5914ef
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 09, 2017
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 | 1909 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1404 |
| 3 | A medical device with high risk that requires premarket approval | 12 |
| U | Unclassified | 15 |