Duns Number:942377524
Device Description: The Fracture Body Trial is used to evaluate the size and fit of the implant.
Catalog Number
-
Brand Name
Titan™
Version/Model Number
T95002008STD
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
7b0770d0-69e9-4794-a2c6-e8355f6f5e75
Public Version Date
February 07, 2019
Public Version Number
4
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 |