Duns Number:615789729
Device Description: Avenue T Cage H8mm L30mm 0°
Catalog Number
AT0012P
Brand Name
Avenue T
Version/Model Number
AT0012P
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
K161173
Product Code
OVD
Product Code Name
Intervertebral Fusion Device With Integrated Fixation, Lumbar
Public Device Record Key
f55e14a5-f5ad-475e-befc-f5315d17496f
Public Version Date
March 10, 2022
Public Version Number
4
DI Record Publish Date
April 12, 2017
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 | 433 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2452 |
| 3 | A medical device with high risk that requires premarket approval | 61 |
| U | Unclassified | 40 |