Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart F — Neurological Therapeutic Devices](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices) → [21 CFR 882.5250](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5250) → GXR — Cover, Burr Hole # GXR · Cover, Burr Hole _Neurology · 21 CFR 882.5250 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXR ## Overview - **Product Code:** GXR - **Device Name:** Cover, Burr Hole - **Regulation:** [21 CFR 882.5250](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5250) - **Device Class:** 2 - **Review Panel:** [Neurology](/submissions/NE) - **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](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXR/K253447.md) | Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) | Orthocon, Inc. | Mar 16, 2026 | SESE | | [K240137](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXR/K240137.md) | Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System | Neos Surgery S.L | Feb 16, 2024 | SESE | | [K221606](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXR/K221606.md) | Absorbable Cranial Flap Fixation System | Chendu Medart Medical Scientific Co., Ltd. | Nov 21, 2023 | SESE | | [K192310](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXR/K192310.md) | Flap Fixator, Burr Hole Cover | Ossaware Biotech Co., Ltd. | Jun 3, 2020 | SESE | | [K192162](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXR/K192162.md) | NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate | Neurovention, LLC | Mar 13, 2020 | SESE | | [K181539](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXR/K181539.md) | OSSDSIGN Cranioplug | Ossdsign AB | Oct 12, 2018 | SESE | | [K181382](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXR/K181382.md) | GuardianTM Burr Hole Cover System | St Jude Medical | Jul 20, 2018 | SESE | | [K160739](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXR/K160739.md) | Cranial COVER | Neos Surgery S.L | Jun 12, 2016 | SESE | | [K152342](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXR/K152342.md) | Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover | St Jude Medical | Jun 9, 2016 | SESE | | [K140309](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXR/K140309.md) | CRANIOPLUG | Ossdsign AB | Oct 3, 2014 | SESE | | [K141368](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXR/K141368.md) | NEUROPACE BURR HOLE COVER | NeuroPace, Inc. | Jul 11, 2014 | SESE | | [K132044](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXR/K132044.md) | CRANIAL LOOP, CRANIAL LOOP L AND CRANIAL LOOP XL AND CRANIAL BONE FIXATION SYSTEM | Neos Surgery S.L | Sep 30, 2013 | SESE | | [K123633](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXR/K123633.md) | TRS CRANIAL BONE VOID FILLER(TRS C-BVF) | Tissue Regeneration Systems, Inc. | Aug 16, 2013 | SESE | | [K130309](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXR/K130309.md) | RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM | Biomet Microfixation | Jun 17, 2013 | SESE | | [K123163](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXR/K123163.md) | NEUROPACE BURR HOLE COVER MODEL 8110 | NeuroPace, Inc. | Jan 18, 2013 | SESE | | [K101235](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXR/K101235.md) | CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM | Neos Surgery S.L | Oct 25, 2010 | SESE | | [K091692](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXR/K091692.md) | AESCULAP PEEK CRANIOFIX | Aesculap, Inc. | Aug 12, 2010 | SESE | | [K071138](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXR/K071138.md) | CRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEM | Prosurg, Inc. | Aug 15, 2007 | SESE | | [K042986](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXR/K042986.md) | MODIFICATION TO SYNTHES (USA) (SYNTHES) LOW PROFILE NEURO SYSTEM | Synthes (Usa) | Nov 17, 2004 | SESE | | [K041611](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXR/K041611.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXR](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXR) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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