NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate
FDA 510(k) clearance K192162 · decided 2020-03-13
Clearance details
- K-number
- K192162
- Device name
- NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate
- Applicant
- Neurovention, LLC
- Decision
- Substantially Equivalent
- Date received
- 2019-08-09
- Decision date
- 2020-03-13
- Days to decision
- 217 days
- Clearance type
- Traditional
- Product code
- GXR
- Device class
- 2
- Regulation number
- 882.5250
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Daytona Beach, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) (K253447) | Orthocon, Inc. | 2026-03-16 |
| Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System (K240137) | Neos Surgery S.L | 2024-02-16 |
| Absorbable Cranial Flap Fixation System (K221606) | Chendu Medart Medical Scientific Co., Ltd. | 2023-11-21 |
| Flap Fixator, Burr Hole Cover (K192310) | Ossaware Biotech Co., Ltd. | 2020-06-03 |
| OSSDSIGN Cranioplug (K181539) | Ossdsign AB | 2018-10-12 |
| GuardianTM Burr Hole Cover System (K181382) | St Jude Medical | 2018-07-20 |
| Cranial COVER (K160739) | Neos Surgery S.L | 2016-06-12 |
| Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover (K152342) | St Jude Medical | 2016-06-09 |
| CRANIOPLUG (K140309) | Ossdsign AB | 2014-10-03 |
| NEUROPACE BURR HOLE COVER (K141368) | NeuroPace, Inc. | 2014-07-11 |
| CRANIAL LOOP, CRANIAL LOOP L AND CRANIAL LOOP XL AND CRANIAL BONE FIXATION SYSTEM (K132044) | Neos Surgery S.L | 2013-09-30 |
| TRS CRANIAL BONE VOID FILLER(TRS C-BVF) (K123633) | Tissue Regeneration Systems, Inc. | 2013-08-16 |
Recalls involving this device
No recalls on record reference this clearance.