Product code GXR
- Device name
- Cover, Burr Hole
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.5250
- Review panel
- NE
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253447 | Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) | Orthocon, Inc. | 2026-03-16 |
| K240137 | Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System | Neos Surgery S.L | 2024-02-16 |
| K221606 | Absorbable Cranial Flap Fixation System | Chendu Medart Medical Scientific Co., Ltd. | 2023-11-21 |
| K192310 | Flap Fixator, Burr Hole Cover | Ossaware Biotech Co., Ltd. | 2020-06-03 |
| K192162 | NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate | Neurovention, LLC | 2020-03-13 |
| K181539 | OSSDSIGN Cranioplug | Ossdsign AB | 2018-10-12 |
| K181382 | GuardianTM Burr Hole Cover System | St Jude Medical | 2018-07-20 |
| K160739 | Cranial COVER | Neos Surgery S.L | 2016-06-12 |
| K152342 | Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover | St Jude Medical | 2016-06-09 |
| K140309 | CRANIOPLUG | Ossdsign AB | 2014-10-03 |
| K141368 | NEUROPACE BURR HOLE COVER | NeuroPace, Inc. | 2014-07-11 |
| K132044 | CRANIAL LOOP, CRANIAL LOOP L AND CRANIAL LOOP XL AND CRANIAL BONE FIXATION SYSTEM | Neos Surgery S.L | 2013-09-30 |
| K123633 | TRS CRANIAL BONE VOID FILLER(TRS C-BVF) | Tissue Regeneration Systems, Inc. | 2013-08-16 |
| K130309 | RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM | Biomet Microfixation | 2013-06-17 |
| K123163 | NEUROPACE BURR HOLE COVER MODEL 8110 | NeuroPace, Inc. | 2013-01-18 |
| K101235 | CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM | Neos Surgery S.L | 2010-10-25 |
| K091692 | AESCULAP PEEK CRANIOFIX | Aesculap, Inc. | 2010-08-12 |
| K071138 | CRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEM | Prosurg, Inc. | 2007-08-15 |
| K042986 | MODIFICATION TO SYNTHES (USA) (SYNTHES) LOW PROFILE NEURO SYSTEM | Synthes (Usa) | 2004-11-17 |
| K041611 | SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMP | Synthes (Usa) | 2004-09-08 |
| K040080 | AESCULAP ABSORBABLE CRANIOFIX | Aesculap, Inc. | 2004-03-31 |
| K031654 | SYNTHES RESORBABLE CRANIAL CLAMP, (MODIFIED) | Synthes (Usa) | 2003-08-08 |
| K021408 | RESORBABLE CRANIAL CLAMPS | Synthes (Usa) | 2002-07-29 |
| K010361 | MEDTRONIC PS MEDICAL INVISX CRANIAL FIXATION SYSTEM, MODEL 60100-60900 | Medtronic PS Medical | 2001-05-07 |
| K002334 | MACROPORENS CRANILOC | Macropore Biosurgery, Inc. | 2001-05-02 |
| K001096 | BURR HOLE COVER, MODEL XX | Image-Guided Neurologics, Inc. | 2000-10-25 |
| K960656 | GORE BURR HOLE COVER | W. L. Gore & Associates, Inc. | 1996-08-14 |
| K913490 | PHOENIX BURR HOLE BUTTON, BURR 1 | Phoenix Bioengineering, Inc. | 1992-01-13 |
| K853367 | H-H BURR HOLE CATHETER SUPPORT | Holter-Hausner Intl. | 1985-09-11 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613252444268 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613252657163 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613252645061 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613252645054 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613252616108 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613252600169 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613252600152 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613252600145 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613252529002 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613252528999 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613252496809 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613252496793 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613252467502 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613252448808 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613252448792 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613153066828 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613252444251 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613252444237 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613252444220 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613252444213 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613252313083 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613252313076 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613252270775 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613252270768 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613252256274 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613252009597 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613252009580 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613154991143 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613154629077 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613153066842 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |