Duns Number:081840873
Device Description: STEM, HIP, ALPHA II, 15 L, MODULAR. RV, BOWED
Catalog Number
-
Brand Name
DJO SURGICAL
Version/Model Number
652-04-150L
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
K000817
Product Code
JDI
Product Code Name
Prosthesis, hip, semi-constrained, metal/polymer, cemented
Public Device Record Key
53b2cfcd-7b21-44f7-9990-5717dbe58a45
Public Version Date
August 30, 2019
Public Version Number
1
DI Record Publish Date
August 22, 2019
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 | 784 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1030 |
| 3 | A medical device with high risk that requires premarket approval | 8 |