Duns Number:320249162
Device Description: MOSS Ti Pedicle Screw Ø11.0x100mm DL, polyaxial, green
Catalog Number
107-018-E100
Brand Name
NA
Version/Model Number
107-018-E100
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
-
Product Code
NKB
Product Code Name
Thoracolumbosacral pedicle screw system
Public Device Record Key
dd34b3b7-2a67-47a4-a147-3e132bcebd46
Public Version Date
September 24, 2021
Public Version Number
1
DI Record Publish Date
September 16, 2021
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 | 359 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 876 |