Duns Number:942377524
Device Description: The Fin-Lock Glenoid implant is part of the Titan Modular Shoulder System. It is an anchor The Fin-Lock Glenoid implant is part of the Titan Modular Shoulder System. It is an anchor peg that is used in patients with severely painful and/or disabled joint, fracture-dislocations, and other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable. The glenoid component is intended for cemented use only.
Catalog Number
-
Brand Name
TITAN™
Version/Model Number
GLN-0926-030-01A
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
K152047
Product Code
KWS
Product Code Name
PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
Public Device Record Key
d1c5c0f0-7028-4c31-a83d-798abfdd4b39
Public Version Date
December 23, 2019
Public Version Number
4
DI Record Publish Date
May 19, 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 |