Duns Number:024163331
Device Description: Titanium alloy posts are used to affix the proximal end of the plate to the proximal end o Titanium alloy posts are used to affix the proximal end of the plate to the proximal end of the humerus. With the aid of fixtures, the posts have the ability to have cross elements inserted perpendicular to the axis of the cortical thread of the post. The head of the post is a threaded locking configuration that accepts an expansion cap screw. The posts are 5.25mm in diameter and are available in 5 lengths ranging from 30mm to 50mm.
Catalog Number
TO-52-P-35
Brand Name
5.2mm Post, 35mm
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
8729163e-fe1d-4986-a47f-d846e38632d7
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 |