Duns Number:942377524
Device Description: The Titan Modular Total Shoulder primary body is shaped to provide proximal fixation and i The Titan Modular Total Shoulder primary body is shaped to provide proximal fixation and is designed to accommodate the natural humeral geometry, while providing stable fixation, proximal bone loading and proper head placement.
Catalog Number
BOD-0923-020-12STD
Brand Name
Titan™ Total Shoulder System
Version/Model Number
BOD-0923-020-12STD
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
K142413
Product Code
HSD
Product Code Name
PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
Public Device Record Key
ded0b270-a737-4322-a616-4503372dedd7
Public Version Date
June 23, 2020
Public Version Number
4
DI Record Publish Date
October 09, 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 | 1909 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1404 |
| 3 | A medical device with high risk that requires premarket approval | 12 |
| U | Unclassified | 15 |