Duns Number:079375910
Device Description: Poly-Axial Screw, Solid, Ø8.5mm x 80mm
Catalog Number
3PS85-80-01
Brand Name
NEO Modera Pedicle Screw System
Version/Model Number
A
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K141253
Product Code
MNI
Product Code Name
Orthosis, Spinal Pedicle Fixation
Public Device Record Key
3cf7dd75-15bd-4567-a5ba-1a406a19d714
Public Version Date
May 15, 2020
Public Version Number
4
DI Record Publish Date
October 25, 2016
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 256 |