Duns Number:649185170
Device Description: A surgical tool intended for discectomy and eroding of the lumbar cage endplate. Once rota A surgical tool intended for discectomy and eroding of the lumbar cage endplate. Once rotated, the Shaver width also enables estimation of the intervertebral space height.
Catalog Number
CCLC9013
Brand Name
CarboClear Lumbar Cage System
Version/Model Number
Shaver – 13 mm
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
faad54ff-646e-4da1-9f58-6161787473f1
Public Version Date
June 08, 2020
Public Version Number
1
DI Record Publish Date
May 31, 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 |