Duns Number:783908713
Device Description: ORIO-Ti - ALIF Cage, Small 23 x 31 x 18mm, 15 deg.
Catalog Number
A7S15-18-Ti
Brand Name
ORIO-Ti Cage System
Version/Model Number
A7S15-18-Ti
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"
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
K211935
Product Code
MAX
Product Code Name
Intervertebral fusion device with bone graft, lumbar
Public Device Record Key
5553afa7-cc93-4dd7-806a-cdde91fbcbcc
Public Version Date
October 25, 2021
Public Version Number
1
DI Record Publish Date
October 15, 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 | 1247 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15504 |