FDA 510(k) Applications for Medical Device Product Code "GXR"
(Cover, Burr Hole)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K040080 | AESCULAP, INC. | AESCULAP ABSORBABLE CRANIOFIX | 03/31/2004 |
| K091692 | AESCULAP, INC. | AESCULAP PEEK CRANIOFIX | 08/12/2010 |
| K130309 | BIOMET MICROFIXATION | RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM | 06/17/2013 |
| K221606 | Chendu MedArt Medical Scientific Co., Ltd. | Absorbable Cranial Flap Fixation System | 11/21/2023 |
| K001096 | IMAGE-GUIDED NEUROLOGICS, INC. | BURR HOLE COVER, MODEL XX | 10/25/2000 |
| K002334 | MACROPORE BIOSURGERY, INC. | MACROPORENS CRANILOC | 05/02/2001 |
| K010361 | MEDTRONIC PS MEDICAL | MEDTRONIC PS MEDICAL INVISX CRANIAL FIXATION SYSTEM, MODEL 60100-60900 | 05/07/2001 |
| K240137 | Neos Surgery S.L | Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System | 02/16/2024 |
| K160739 | Neos Surgery S.L. | Cranial COVER | 06/12/2016 |
| K101235 | NEOS SURGERY S.L. | CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM | 10/25/2010 |
| K132044 | NEOS SURGERY S.L. | CRANIAL LOOP, CRANIAL LOOP L AND CRANIAL LOOP XL AND CRANIAL BONE FIXATION SYSTEM | 09/30/2013 |
| K141368 | NEUROPACE INC | NEUROPACE BURR HOLE COVER | 07/11/2014 |
| K123163 | NEUROPACE INC | NEUROPACE BURR HOLE COVER MODEL 8110 | 01/18/2013 |
| K192162 | NeuroVention LLC | NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate | 03/13/2020 |
| K192310 | Ossaware Biotech Co., Ltd. | Flap Fixator, Burr Hole Cover | 06/03/2020 |
| K140309 | OSSDSIGN AB | CRANIOPLUG | 10/03/2014 |
| K181539 | OssDsign AB | OSSDSIGN Cranioplug | 10/12/2018 |
| K071138 | PROSURG, INC. | CRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEM | 08/15/2007 |
| K181382 | St Jude Medical | GuardianTM Burr Hole Cover System | 07/20/2018 |
| K152342 | ST. JUDE MEDICAL | Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover | 06/09/2016 |
| K042986 | SYNTHES (USA) | MODIFICATION TO SYNTHES (USA) (SYNTHES) LOW PROFILE NEURO SYSTEM | 11/17/2004 |
| K021408 | SYNTHES (USA) | RESORBABLE CRANIAL CLAMPS | 07/29/2002 |
| K041611 | SYNTHES (USA) | SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMP | 09/08/2004 |
| K031654 | SYNTHES (USA) | SYNTHES RESORBABLE CRANIAL CLAMP, (MODIFIED) | 08/08/2003 |
| K123633 | TISSUE REGENERATION SYSTEMS, INC. | TRS CRANIAL BONE VOID FILLER(TRS C-BVF) | 08/16/2013 |
| K960656 | W.L. GORE & ASSOCIATES,INC | GORE BURR HOLE COVER | 08/14/1996 |
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