Duns Number:344203948
Device Description: The VERTACONNECT TLIF Spreadable Lumbar Cage is a spacer for implantation in aprepared int The VERTACONNECT TLIF Spreadable Lumbar Cage is a spacer for implantation in aprepared intervertebral disc space of the lumbar spine. Its design offers stable contactsurfaces, toothed implant/bone surfaces and large cage windows. The open implant design supports a bony construction of the intervertebral disc space. The implants consist of a cage and a pre-assembled expansion element.
Catalog Number
CAT311308
Brand Name
VERTACONNECT 11°
Version/Model Number
Lumbar cage, angled
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
K203327
Product Code
MAX
Product Code Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Public Device Record Key
431d4b44-7253-411c-a116-0e5db18dd7ee
Public Version Date
March 26, 2021
Public Version Number
1
DI Record Publish Date
March 18, 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 | 522 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1837 |