Duns Number:154074504
Device Description: ALTIVATE ANATOMIC CS, HUMERAL NECK
Catalog Number
-
Brand Name
DJO SURGICAL
Version/Model Number
520-08-001
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
K193226
Product Code
PKC
Product Code Name
Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained
Public Device Record Key
4884fed2-4595-432d-92dd-156e813c2819
Public Version Date
July 20, 2020
Public Version Number
1
DI Record Publish Date
July 10, 2020
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 |