Duns Number:344203948
Device Description: The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two
Catalog Number
AB0156-55025
Brand Name
DIPLOMAT
Version/Model Number
Offset connector open
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
K151704
Product Code
MNH
Product Code Name
Orthosis, Spondylolisthesis Spinal Fixation
Public Device Record Key
8bf8899f-6e3b-4f5d-8b6c-53b592f18a08
Public Version Date
October 09, 2019
Public Version Number
2
DI Record Publish Date
September 20, 2018
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 | 522 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1837 |