Duns Number:024163331
Device Description: Titanium alloy cross elements are designed to provide additional support to the humeral he Titanium alloy cross elements are designed to provide additional support to the humeral head by entering the posts perpendicular to the axis of the cortical thread of the posts.
Catalog Number
TO-20-CE-30
Brand Name
2.0mm Cross Element, 30mm
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
55b8d978-f335-43de-bfa9-e88b2e3389a0
Public Version Date
August 17, 2020
Public Version Number
1
DI Record Publish Date
August 07, 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 |