Duns Number:942377524
Device Description: The Capture Screw System is comprised of Digital screws used for bone fixation of the hand The Capture Screw System is comprised of Digital screws used for bone fixation of the hand and foot, following trauma or osteotomy. All screws are made from Titanium Alloy, and instrumentation is made from titanium and stainless steel. The Digital Screw is a cannulated, threaded bone screw which is offered in a 2.0mm diameter with lengths of 24 – 50mm. The system includes instruments to facilitate the placement of the screws.
Catalog Number
CAPDIGITIMP
Brand Name
CAPTURE™ Screw System
Version/Model Number
CAPDIGITIMP
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
-
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
bb449bda-3db8-4748-8db9-8b997f2efc7b
Public Version Date
July 16, 2020
Public Version Number
4
DI Record Publish Date
September 22, 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 | 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 |