Duns Number:079293587
Device Description: 7.3/25mm FT Flow-Screw
Catalog Number
73-2025
Brand Name
Flow-Screw™
Version/Model Number
73-2025
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K142776
Product Code
HWC
Product Code Name
Screw, Fixation, Bone
Public Device Record Key
2f297d4e-5a5a-47a0-8668-da8ce5c00d24
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 04, 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 | 85 |
2 | A medical device with a moderate to high risk that requires special controls. | 1067 |