FDA Product Code
FDA Product Code GXR — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.5250
510(k) Clearances — 29 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253447 | Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) | Orthocon, Inc. | 2026-03-16 | Traditional | PDF ↗ |
| K240137 | Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System | Neos Surgery S.L | 2024-02-16 | Special | PDF ↗ |
| K221606 | Absorbable Cranial Flap Fixation System | Chendu Medart Medical Scientific Co., Ltd. | 2023-11-21 | Traditional | PDF ↗ |
| K192310 | Flap Fixator, Burr Hole Cover | Ossaware Biotech Co., Ltd. | 2020-06-03 | Traditional | PDF ↗ |
| K192162 | NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate | Neurovention, LLC | 2020-03-13 | Traditional | PDF ↗ |
| K181539 | OSSDSIGN Cranioplug | Ossdsign AB | 2018-10-12 | Traditional | PDF ↗ |
| K181382 | GuardianTM Burr Hole Cover System | St Jude Medical | 2018-07-20 | Abbreviated | PDF ↗ |
| K160739 | Cranial COVER | Neos Surgery S.L | 2016-06-12 | Traditional | PDF ↗ |
| K152342 | Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover | St Jude Medical | 2016-06-09 | Traditional | PDF ↗ |
| K140309 | CRANIOPLUG | Ossdsign AB | 2014-10-03 | Traditional | PDF ↗ |
| K141368 | NEUROPACE BURR HOLE COVER | NeuroPace, Inc. | 2014-07-11 | Special | PDF ↗ |
| K132044 | CRANIAL LOOP, CRANIAL LOOP L AND CRANIAL LOOP XL AND CRANIAL BONE FIXATION SYSTEM | Neos Surgery S.L | 2013-09-30 | Traditional | PDF ↗ |
| K123633 | TRS CRANIAL BONE VOID FILLER(TRS C-BVF) | Tissue Regeneration Systems, Inc. | 2013-08-16 | Traditional | PDF ↗ |
| K130309 | RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM | Biomet Microfixation | 2013-06-17 | Traditional | PDF ↗ |
| K123163 | NEUROPACE BURR HOLE COVER MODEL 8110 | NeuroPace, Inc. | 2013-01-18 | Traditional | PDF ↗ |
| K101235 | CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM | Neos Surgery S.L | 2010-10-25 | Traditional | PDF ↗ |
| K091692 | AESCULAP PEEK CRANIOFIX | Aesculap, Inc. | 2010-08-12 | Traditional | PDF ↗ |
| K071138 | CRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEM | Prosurg, Inc. | 2007-08-15 | Traditional | PDF ↗ |
| K042986 | MODIFICATION TO SYNTHES (USA) (SYNTHES) LOW PROFILE NEURO SYSTEM | Synthes (Usa) | 2004-11-17 | Special | PDF ↗ |
| K041611 | SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMP | Synthes (Usa) | 2004-09-08 | Traditional | PDF ↗ |
| K040080 | AESCULAP ABSORBABLE CRANIOFIX | Aesculap, Inc. | 2004-03-31 | Traditional | PDF ↗ |
| K031654 | SYNTHES RESORBABLE CRANIAL CLAMP, (MODIFIED) | Synthes (Usa) | 2003-08-08 | Traditional | PDF ↗ |
| K021408 | RESORBABLE CRANIAL CLAMPS | Synthes (Usa) | 2002-07-29 | Traditional | PDF ↗ |
| K010361 | MEDTRONIC PS MEDICAL INVISX CRANIAL FIXATION SYSTEM, MODEL 60100-60900 | Medtronic PS Medical | 2001-05-07 | Traditional | PDF ↗ |
| K002334 | MACROPORENS CRANILOC | Macropore Biosurgery, Inc. | 2001-05-02 | Traditional | PDF ↗ |
| K001096 | BURR HOLE COVER, MODEL XX | Image-Guided Neurologics, Inc. | 2000-10-25 | Traditional | PDF ↗ |
| K960656 | GORE BURR HOLE COVER | W. L. Gore & Associates, Inc. | 1996-08-14 | Traditional | PDF ↗ |
| K913490 | PHOENIX BURR HOLE BUTTON, BURR 1 | Phoenix Bioengineering, Inc. | 1992-01-13 | Traditional | PDF ↗ |
| K853367 | H-H BURR HOLE CATHETER SUPPORT | Holter-Hausner Intl. | 1985-09-11 | Traditional | PDF ↗ |
Product code GXR · Class II · Neurology. Data: openFDA.