Duns Number:344203948
Device Description: The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two
Catalog Number
LSZ3001/S
Brand Name
DIPLOMAT Def.
Version/Model Number
Round rod, straight, hex connector
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,K151704
Product Code
MNH
Product Code Name
Orthosis, Spondylolisthesis Spinal Fixation
Public Device Record Key
dc346279-0ccc-475a-b9a1-d5039658943f
Public Version Date
November 06, 2019
Public Version Number
1
DI Record Publish Date
October 29, 2019
Package DI Number
04047844036310
Quantity per Package
2
Contains DI Package
04047844036303
Package Discontinue Date
-
Package Status
In Commercial Distribution
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 |