Cover, Burr Hole
FDA product code GXR · Class II (moderate risk) · 21 CFR 882.5250 · Neurology
29510(k) clearances
0PMA approvals
1recalls
Implantimplanted device
Manufacturers
- Synthes (Usa) 4
- Neos Surgery S.L 4
- St Jude Medical 2
- Aesculap, Inc. 2
- Ossdsign AB 2
- NeuroPace, Inc. 2
- Orthocon, Inc. 1
- Holter-Hausner Intl. 1
- Chendu Medart Medical Scientific Co., Ltd. 1
- Ossaware Biotech Co., Ltd. 1
- Neurovention, LLC 1
- Tissue Regeneration Systems, Inc. 1
- Biomet Microfixation, Inc. 1
- Prosurg, Inc. 1
- Medtronic PS Medical 1
- Macropore Biosurgery, Inc. 1
- Image-Guided Neurologics, Inc. 1
- W. L. Gore & Associates, Inc. 1
- Phoenix Bioengineering, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253447 | Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)GXR · Traditional | Orthocon, Inc. | 03/16/2026SE |
| K240137 | Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation SystemGXR · Special | Neos Surgery S.L | 02/16/2024SE |
| K221606 | Absorbable Cranial Flap Fixation SystemGXR · Traditional | Chendu Medart Medical Scientific Co., Ltd. | 11/21/2023SE |
| K192310 | Flap Fixator, Burr Hole CoverGXR · Traditional | Ossaware Biotech Co., Ltd. | 06/03/2020SE |
| K192162 | NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC PlateGXR · Traditional | Neurovention, LLC | 03/13/2020SE |
| K181539 | OSSDSIGN CranioplugGXR · Traditional | Ossdsign AB | 10/12/2018SE |
| K181382 | GuardianTM Burr Hole Cover SystemGXR · Abbreviated | St Jude Medical | 07/20/2018SE |
| K160739 | Cranial COVERGXR · Traditional | Neos Surgery S.L | 06/12/2016SE |
| K152342 | Guardian Burr Hole Cover System, Guardian Screw, Burr Hole CoverGXR · Traditional | St Jude Medical | 06/09/2016SE |
| K140309 | CranioplugGXR · Traditional | Ossdsign AB | 10/03/2014SE |
| K141368 | Neuropace Burr Hole CoverGXR · Special | NeuroPace, Inc. | 07/11/2014SE |
| K132044 | Cranial Loop, Cranial Loop L and Cranial Loop XL and Cranial Bone Fixation SystemGXR · Traditional | Neos Surgery S.L | 09/30/2013SE |
| K123633 | TRS Cranial Bone Void Filler(Trs C-Bvf)GXR · Traditional | Tissue Regeneration Systems, Inc. | 08/16/2013SE |
| K130309 | Rapidflap LS Cranial Flap Fixation SystemGXR · Traditional | Biomet Microfixation | 06/17/2013SE |
| K123163 | Neuropace Burr Hole Cover Model 8110GXR · Traditional | NeuroPace, Inc. | 01/18/2013SE |
| K101235 | Cranial Loop Cranial Bone Fixation SystemGXR · Traditional | Neos Surgery S.L | 10/25/2010SE |
| K091692 | Aesculap PEEK CraniofixGXR · Traditional | Aesculap, Inc. | 08/12/2010SE |
| K071138 | Cranioclamp Bioabsorbable Cranial Bone Flap Fixation SystemGXR · Traditional | Prosurg, Inc. | 08/15/2007SE |
| K042986 | Modification to Synthes (USA) (Synthes) Low Profile Neuro SystemGXR · Special | Synthes (Usa) | 11/17/2004SE |
| K041611 | Synthes (USA) Rapid Resorbable Cranial ClampGXR · Traditional | Synthes (Usa) | 09/08/2004SE |
| K040080 | Aesculap Absorbable CraniofixGXR · Traditional | Aesculap, Inc. | 03/31/2004SE |
| K031654 | Synthes Resorbable Cranial Clamp, (Modified)GXR · Traditional | Synthes (Usa) | 08/08/2003SE |
| K021408 | Resorbable Cranial ClampsGXR · Traditional | Synthes (Usa) | 07/29/2002SE |
| K010361 | Medtronic PS Medical Invisx Cranial Fixation System, Model 60100-60900GXR · Traditional | Medtronic PS Medical | 05/07/2001SE |
| K002334 | Macroporens CranilocGXR · Traditional | Macropore Biosurgery, Inc. | 05/02/2001SE |
| K001096 | Burr Hole Cover, Model XXGXR · Traditional | Image-Guided Neurologics, Inc. | 10/25/2000SE |
| K960656 | Gore Burr Hole CoverGXR · Traditional | W. L. Gore & Associates, Inc. | 08/14/1996SE |
| K913490 | Phoenix Burr Hole Button, Burr 1GXR · Traditional | Phoenix Bioengineering, Inc. | 01/13/1992SE |
| K853367 | H-H Burr Hole Catheter SupportGXR · Traditional | Holter-Hausner Intl. | 09/11/1985SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2228-2021 Class II | Medtronic StimLoc Burr Hole Cover, Part Numbers: a) 3387S-40 b) 3389S-28 c) 3389S-40 d)…Excess nylon flash on the clip. | Medtronic Neuromodulation | 06/02/2021Open, Classified |