Duns Number:315675488
Device Description: Humeral Head
Catalog Number
642-041/15
Brand Name
LINK Embrace Shoulder System
Version/Model Number
642-041/15
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
K210899
Product Code
HSD
Product Code Name
PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
Public Device Record Key
503508ab-5111-4cb3-aac1-347430950eac
Public Version Date
October 15, 2021
Public Version Number
1
DI Record Publish Date
October 07, 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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 154 |
2 | A medical device with a moderate to high risk that requires special controls. | 3922 |
U | Unclassified | 42 |