Duns Number:074912476
Device Description: The NeuroVention Cranial Fixation System is intended for use as a burr hole cover and/or s The NeuroVention Cranial Fixation System is intended for use as a burr hole cover and/or skull bone fixation followingcraniotomy, cranioplasty, or craniectomy surgery. KTC 3-piece plate is made from PEEK.
Catalog Number
-
Brand Name
KTC Burr Hole Cover
Version/Model Number
410-01
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Conditional
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
K192162
Product Code
GWO
Product Code Name
Plate, Cranioplasty, Preformed, Alterable
Public Device Record Key
6e16b093-ba85-4a7c-b9a7-0741745aeb57
Public Version Date
June 29, 2022
Public Version Number
1
DI Record Publish Date
June 21, 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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |