Duns Number:592616445
Device Description: Intended to be used for the insertion of spinal implants and trials into the spinal space Intended to be used for the insertion of spinal implants and trials into the spinal space during total artificial disc replacement surgery.
Catalog Number
LET30310T
Brand Name
CONDUIT LLIF Angled Inserter – Hex Driver
Version/Model Number
LET30310T
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MAX
Product Code Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Public Device Record Key
a9ca175c-12a2-458d-b15f-b9821aa5d17f
Public Version Date
February 03, 2022
Public Version Number
1
DI Record Publish Date
January 26, 2022
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 | 107 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |