Cover, Burr Hole
Regulation 882.5250
1510(k)s in 12 months (29 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in GXR
| Company | 510(k)s | Recalls |
|---|---|---|
| Neos Surgery S.L | 4 | 0 |
| Synthes (Usa) | 4 | 0 |
| Aesculap, Inc. | 2 | 0 |
| NeuroPace, Inc. | 2 | 0 |
| Ossdsign AB | 2 | 0 |
| St Jude Medical | 2 | 0 |
| Biomet Microfixation | 1 | 0 |
| Chendu Medart Medical Scientific Co., Ltd. | 1 | 0 |
| Holter-Hausner Intl. | 1 | 0 |
| Image-Guided Neurologics, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 16, 2026 | K253447 | Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) Orthocon, Inc. | GXR |
| Feb 16, 2024 | K240137 | Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System Neos Surgery S.L, ES | GXR |
| Nov 21, 2023 | K221606 | Absorbable Cranial Flap Fixation System Chendu Medart Medical Scientific Co., Ltd., CN | GXR |
| Jun 3, 2020 | K192310 | Flap Fixator, Burr Hole Cover Ossaware Biotech Co., Ltd., TW | GXR |
| Mar 13, 2020 | K192162 | NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate Neurovention, LLC | GXR |
| Oct 12, 2018 | K181539 | OSSDSIGN Cranioplug Ossdsign AB, SE | GXR |
| Jul 20, 2018 | K181382 | GuardianTM Burr Hole Cover System St Jude Medical | GXR |
| Jun 12, 2016 | K160739 | Cranial COVER Neos Surgery S.L, ES | GXR |
| Jun 9, 2016 | K152342 | Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover St Jude Medical | GXR |
| Oct 3, 2014 | K140309 | CRANIOPLUG Ossdsign AB | GXR |
| Jul 11, 2014 | K141368 | NEUROPACE BURR HOLE COVER NeuroPace, Inc. | GXR |
| Sep 30, 2013 | K132044 | CRANIAL LOOP, CRANIAL LOOP L AND CRANIAL LOOP XL AND CRANIAL BONE FIXATION SYSTEM Neos Surgery S.L | GXR |
| Aug 16, 2013 | K123633 | TRS CRANIAL BONE VOID FILLER(TRS C-BVF) Tissue Regeneration Systems, Inc. | GXR |
| Jun 17, 2013 | K130309 | RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM Biomet Microfixation | GXR |
| Jan 18, 2013 | K123163 | NEUROPACE BURR HOLE COVER MODEL 8110 NeuroPace, Inc. | GXR |
| Oct 25, 2010 | K101235 | CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM Neos Surgery S.L | GXR |
| Aug 12, 2010 | K091692 | AESCULAP PEEK CRANIOFIX Aesculap, Inc. | GXR |
| Aug 15, 2007 | K071138 | CRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEM Prosurg, Inc. | GXR |
| Nov 17, 2004 | K042986 | MODIFICATION TO SYNTHES (USA) (SYNTHES) LOW PROFILE NEURO SYSTEM Synthes (Usa) | GXR |
| Sep 8, 2004 | K041611 | SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMP Synthes (Usa) | GXR |
| Mar 31, 2004 | K040080 | AESCULAP ABSORBABLE CRANIOFIX Aesculap, Inc. | GXR |
| Aug 8, 2003 | K031654 | SYNTHES RESORBABLE CRANIAL CLAMP, (MODIFIED) Synthes (Usa) | GXR |
| Jul 29, 2002 | K021408 | RESORBABLE CRANIAL CLAMPS Synthes (Usa) | GXR |
| May 7, 2001 | K010361 | MEDTRONIC PS MEDICAL INVISX CRANIAL FIXATION SYSTEM, MODEL 60100-60900 Medtronic PS Medical | GXR |
| May 2, 2001 | K002334 | MACROPORENS CRANILOC Macropore Biosurgery, Inc. | GXR |
| Oct 25, 2000 | K001096 | BURR HOLE COVER, MODEL XX Image-Guided Neurologics, Inc. | GXR |
| Aug 14, 1996 | K960656 | GORE BURR HOLE COVER W. L. Gore & Associates, Inc. | GXR |
| Jan 13, 1992 | K913490 | PHOENIX BURR HOLE BUTTON, BURR 1 Phoenix Bioengineering, Inc. | GXR |
| Sep 11, 1985 | K853367 | H-H BURR HOLE CATHETER SUPPORT Holter-Hausner Intl. | GXR |
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