Duns Number:080404519
Device Description: Shoulder Innovations InSet Plus Glenoid Trial, Circular Center Peg, 30mm x 5°, Stainless S Shoulder Innovations InSet Plus Glenoid Trial, Circular Center Peg, 30mm x 5°, Stainless Steel
Catalog Number
2N1AC30005
Brand Name
Shoulder Innovations TSA
Version/Model Number
30 mm x 5°
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K111596,K102670,K110905
Product Code
HSD
Product Code Name
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Public Device Record Key
3147cf23-37af-4dea-8039-e62f7a96afa0
Public Version Date
August 10, 2021
Public Version Number
2
DI Record Publish Date
May 04, 2021
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 443 |