Duns Number:081224143
Device Description: 8mm Trial-Rasp Single Assembly, Axle System
Catalog Number
-
Brand Name
Axle Interspinous Fusion System
Version/Model Number
X060-0440
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
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
HTR
Product Code Name
RASP
Public Device Record Key
da3d95bd-ac76-4b81-bcb6-7e95823d2064
Public Version Date
June 03, 2021
Public Version Number
4
DI Record Publish Date
May 26, 2015
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 | 1719 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3162 |
| U | Unclassified | 25 |