Duns Number:109903521
Device Description: RSS 4.5MM STAR SCREW AND CAP 35MM LENGTH
Catalog Number
SCW-0961-046-35
Brand Name
Titan Reverse Shoulder System
Version/Model Number
SCW-0961-046-35
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
K181999
Product Code
PHX
Product Code Name
shoulder prosthesis, reverse configuration
Public Device Record Key
5d7f4e80-44a7-494c-93d2-e1c0fead3e5a
Public Version Date
October 25, 2022
Public Version Number
1
DI Record Publish Date
October 17, 2022
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 | 10651 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
| 3 | A medical device with high risk that requires premarket approval | 351 |