GXR · Cover, Burr Hole
Neurology · 21 CFR 882.5250 · Class 2
Overview
| Product Code | GXR |
|---|---|
| Device Name | Cover, Burr Hole |
| Regulation | 21 CFR 882.5250 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| Implant | Yes |
Identification
A burr hole cover is a plastic or metal device used to cover or plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 29)
Showing 20 most recent of 29 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253447 | Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) | Orthocon, Inc. | Mar 16, 2026 | SESE |
| K240137 | Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System | Neos Surgery S.L | Feb 16, 2024 | SESE |
| K221606 | Absorbable Cranial Flap Fixation System | Chendu Medart Medical Scientific Co., Ltd. | Nov 21, 2023 | SESE |
| K192310 | Flap Fixator, Burr Hole Cover | Ossaware Biotech Co., Ltd. | Jun 3, 2020 | SESE |
| K192162 | NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate | Neurovention, LLC | Mar 13, 2020 | SESE |
| K181539 | OSSDSIGN Cranioplug | Ossdsign AB | Oct 12, 2018 | SESE |
| K181382 | GuardianTM Burr Hole Cover System | St Jude Medical | Jul 20, 2018 | SESE |
| K160739 | Cranial COVER | Neos Surgery S.L | Jun 12, 2016 | SESE |
| K152342 | Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover | St Jude Medical | Jun 9, 2016 | SESE |
| K140309 | CRANIOPLUG | Ossdsign AB | Oct 3, 2014 | SESE |
| K141368 | NEUROPACE BURR HOLE COVER | NeuroPace, Inc. | Jul 11, 2014 | SESE |
| K132044 | CRANIAL LOOP, CRANIAL LOOP L AND CRANIAL LOOP XL AND CRANIAL BONE FIXATION SYSTEM | Neos Surgery S.L | Sep 30, 2013 | SESE |
| K123633 | TRS CRANIAL BONE VOID FILLER(TRS C-BVF) | Tissue Regeneration Systems, Inc. | Aug 16, 2013 | SESE |
| K130309 | RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM | Biomet Microfixation | Jun 17, 2013 | SESE |
| K123163 | NEUROPACE BURR HOLE COVER MODEL 8110 | NeuroPace, Inc. | Jan 18, 2013 | SESE |
| K101235 | CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM | Neos Surgery S.L | Oct 25, 2010 | SESE |
| K091692 | AESCULAP PEEK CRANIOFIX | Aesculap, Inc. | Aug 12, 2010 | SESE |
| K071138 | CRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEM | Prosurg, Inc. | Aug 15, 2007 | SESE |
| K042986 | MODIFICATION TO SYNTHES (USA) (SYNTHES) LOW PROFILE NEURO SYSTEM | Synthes (Usa) | Nov 17, 2004 | SESE |
| K041611 | SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMP | Synthes (Usa) | Sep 8, 2004 | SESE |
Top Applicants
- Neos Surgery S.L — 4 clearances
- Synthes (Usa) — 4 clearances
- Aesculap, Inc. — 2 clearances
- NeuroPace, Inc. — 2 clearances
- Ossdsign AB — 2 clearances
