Duns Number:942377524
Device Description: Titan™ Total Shoulder SystemThe stand is used as a base during stem impaction.
Catalog Number
SIS-0920-054-001
Brand Name
Titan™
Version/Model Number
SS0920054001
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
-
Product Code
LXH
Product Code Name
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Public Device Record Key
9e8abcd8-dd0b-4b13-8342-307a9fa56cf6
Public Version Date
April 21, 2021
Public Version Number
6
DI Record Publish Date
September 05, 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 |