Duns Number:024163331
Device Description: The titanium alloy cortical locking screws (torx T-10 head) are used to affix the plate to The titanium alloy cortical locking screws (torx T-10 head) are used to affix the plate to the humerus. The screws are 3.5mm diameter and are available in various lengths from 10mm to 45mm.
Catalog Number
TO-35-T10-CLS-16
Brand Name
3.5mm T10 Drive Cortical Locking Screw, 16mm
Version/Model Number
NA
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K081608
Product Code
HWC
Product Code Name
Screw, Fixation, Bone
Public Device Record Key
5c1f1996-9f25-4b4a-9907-d0b2c2dc5cee
Public Version Date
August 24, 2020
Public Version Number
1
DI Record Publish Date
August 16, 2020
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 | 41 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 112 |