KTC Burr Hole Cover
The KTC Burr Hole Cover is an implant used to cover an opening in the skull after cranial surgery. It belongs to the NeuroVention Cranial Fixation System, whose stated uses follow…
The KTC Burr Hole Cover is an implant used to cover an opening in the skull after cranial surgery. It belongs to the NeuroVention Cranial Fixation System, whose stated uses follow craniotomy, cranioplasty or craniectomy. The cover provides a physical component for closure of a burr hole.
The system offers covers and plates in different configurations for the surgical site. KTC is specifically identified as a burr hole cover with a 26.5 millimetre size. The listed two piece configuration uses PEEK as its implant material.
Listed Item
The NeuroVention Cranial Fixation System is intended for use as a burr hole cover and/or skull bone fixation following craniotomy, cranioplasty, or craniectomy surgery. KTC 2-piece plate is made from PEEK.
Supply and Preparation
The implant is supplied nonsterile for one use and is steam sterilized by the healthcare facility before implantation. The broader system includes separate instruments for delivery and removal.
Who Else Makes It
Concentrated in Jiangsu (1), Shanghai (1), Shaanxi (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Kontour (Xi’an) Medical Technology Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 4 |
Record
| Listed by | Neurovention, LLC, United States |
|---|---|
| FDA product code | GXR |
| Device type | Cover, Burr Hole |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5250 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K192162 |
| Record published | 2022-06-21 |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 409-01 | In distribution | |
| 410-01 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 1.5MM System | Biomet Microfixation | 90 |
| Bioplate® | Bioplate, Inc. | 48 |
| “2.0MM” System | Biomet Microfixation | 34 |
| Cover, Burr Hole | Biomet Microfixation | 21 |
| Cover, Burr Hole | Synthes Gmbh | 14 |
| Universal Neuro 3 | Stryker Leibinger Gmbh & Co. KG | 12 |
| Cover, Burr Hole | Medtronic, Inc. | 11 |
| “1.0MM” System | Biomet Microfixation | 10 |
| Raas Cranial Plating System | Alliance Partners, LLC | 10 |
| Thinflap System | Biomet Microfixation | 7 |
| Neuro System | Biomet Microfixation | 7 |
| 1.5MM System – Craniocurve (TM) Mesh | Biomet Microfixation | 7 |
Showing 12 of 52. All products under Cover, Burr Hole
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K192162 | 2020-03-13 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.