Duns Number:783908713
Device Description: ORIO-TL STRAIGHT TLIF CAGE, GEN II, 10mm WIDE, 10 X 9 X 28mm
Catalog Number
-
Brand Name
ORIO
Version/Model Number
L7810-09-028
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"
Yes
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
K090887
Product Code
MAX
Product Code Name
Intervertebral fusion device with bone graft, lumbar
Public Device Record Key
dc3ccb4f-953c-4eeb-9073-b8c372d3797f
Public Version Date
February 24, 2020
Public Version Number
4
DI Record Publish Date
September 28, 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 | 1247 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15504 |