Duns Number:942377524
Device Description: The Titan Modular Total Shoulder system is indicated for painful and/or disabled joints, f The Titan Modular Total Shoulder system is indicated for painful and/or disabled joints, fracture-dislocations, and other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable. The humeral tray 3 includes keeled and pegged glenoid trials to evaluate the size and fit of the implant. Glenoid sizers are included to visualize the implant size and anticipate the amount of bone resections. Various instruments are provided to assist with the procedure.
Catalog Number
-
Brand Name
Titan™
Version/Model Number
TSS3IMP
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
-
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
1c8ce90c-ba2e-475b-a957-04baa541359b
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 15, 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 | 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 |