Duns Number:328420633
Device Description: Cortical Screw 3.5, small head, self-tapping, L 32
Catalog Number
SK 3512-32-2
Brand Name
NA
Version/Model Number
SK 3512-32-2
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
K113652
Product Code
HWC
Product Code Name
Screw, fixation, bone
Public Device Record Key
7ec5a5bd-d956-4359-9c88-4e30ffc2266b
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 18, 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 | 738 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2701 |