GXR — Cover, Burr Hole Class II
FDA product code GXR covers "Cover, Burr Hole", a Class II medical device regulated under 21 CFR 882.5250. Submissions are reviewed by the Neurology panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GXR
- Device Class
- Class II
- Regulation Number
- 882.5250
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253447 | orthocon | Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) | March 16, 2026 |
| K240137 | neos surgery s.l | Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System | February 16, 2024 |
| K221606 | chendu medart medical scientific co | Absorbable Cranial Flap Fixation System | November 21, 2023 |
| K192310 | ossaware biotech co | Flap Fixator, Burr Hole Cover | June 3, 2020 |
| K192162 | neurovention | NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Pl | March 13, 2020 |
| K181539 | ossdsign | OSSDSIGN Cranioplug | October 12, 2018 |
| K181382 | st jude medical | GuardianTM Burr Hole Cover System | July 20, 2018 |
| K160739 | neos surgery s.l | Cranial COVER | June 12, 2016 |
| K152342 | st jude medical | Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover | June 9, 2016 |
| K140309 | ossdsign | CRANIOPLUG | October 3, 2014 |
| K141368 | neuropace | NEUROPACE BURR HOLE COVER | July 11, 2014 |
| K132044 | neos surgery s.l | CRANIAL LOOP, CRANIAL LOOP L AND CRANIAL LOOP XL AND CRANIAL BONE FIXATION SYSTE | September 30, 2013 |
| K123633 | tissue regeneration systems | TRS CRANIAL BONE VOID FILLER(TRS C-BVF) | August 16, 2013 |
| K130309 | biomet microfixation | RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM | June 17, 2013 |
| K123163 | neuropace | NEUROPACE BURR HOLE COVER MODEL 8110 | January 18, 2013 |
| K101235 | neos surgery s.l | CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM | October 25, 2010 |
| K091692 | aesculap | AESCULAP PEEK CRANIOFIX | August 12, 2010 |
| K071138 | prosurg | CRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEM | August 15, 2007 |
| K042986 | synthes (usa) | MODIFICATION TO SYNTHES (USA) (SYNTHES) LOW PROFILE NEURO SYSTEM | November 17, 2004 |
| K041611 | synthes (usa) | SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMP | September 8, 2004 |