Duns Number:080506581
Device Description: ACCLAIM ELBOW HINGE PIN UNIT
Catalog Number
172291000
Brand Name
ACCLAIM
Version/Model Number
1722-91-000
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 31, 2022
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
K060696
Product Code
JDB
Product Code Name
PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED
Public Device Record Key
7b5679db-3d8e-4324-a03c-58cc8e728acc
Public Version Date
March 31, 2022
Public Version Number
5
DI Record Publish Date
September 24, 2015
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 | 5254 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4003 |
| 3 | A medical device with high risk that requires premarket approval | 908 |