Duns Number:649185170
Device Description: A surgical tool used for the introduction of the CarboClear Lumbar Cage into the disc spac A surgical tool used for the introduction of the CarboClear Lumbar Cage into the disc space.
Catalog Number
CCLC9040B
Brand Name
CarboClear Lumbar Cage System
Version/Model Number
Cage Inserter – Inner Rod
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K193378
Product Code
MAX
Product Code Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Public Device Record Key
c199dff5-0d37-4496-b15b-5c76219bcde7
Public Version Date
June 05, 2020
Public Version Number
1
DI Record Publish Date
May 28, 2020
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1387 |