Duns Number:154074504
Device Description: ALTIVATE REVERSE, HUMERAL STEM, SMALL SHELL, SZ 10X108MM
Catalog Number
-
Brand Name
DJO SURGICAL
Version/Model Number
533-10-108
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"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K172351
Product Code
HSD
Product Code Name
PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
Public Device Record Key
2cefbaea-6381-4ac3-8784-71d89e0f1893
Public Version Date
July 26, 2018
Public Version Number
4
DI Record Publish Date
December 13, 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 | 2340 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3474 |
| 3 | A medical device with high risk that requires premarket approval | 26 |