Cover, Burr Hole
Neurology · 21 CFR 882.5250
Recent MDR events
210 adverse event reports on file
- STIMLOCApr 24, 2026MalfunctionMedtronic Neuromodulation2182207-2026-01085
- TI MATRIXNEURO ULP BURR HOLE COVER 15MMNov 21, 2025InjurySynthes Gmbh8030965-2025-11720
- 1.5 TI BURR HOLE COVER 17 DIA/6 HOLESNov 19, 2025InjurySynthes Gmbh8030965-2025-11602
- 1.5MM TI BURR HOLE COVER 24MM DIA/6 HOLESNov 19, 2025InjurySynthes Gmbh8030965-2025-11604
- 6 CRANIOFIX BURR HOLE CLAMP ABSORB.16MMAug 22, 2025InjuryAesculap Ag9610612-2025-00172
- STIMLOCAug 21, 2025MalfunctionMedtronic Neuromodulation2182207-2025-02158
- STIMLOCJun 11, 2025MalfunctionMedtronic Neuromodulation2182207-2025-01532
- STIMLOCMay 19, 2025MalfunctionQuality Tech Services Llc3012165443-2025-00032
- 6 CRANIOFIX ABSORBABL.CLAMP STERILE 11MMApr 29, 2025InjuryAesculap Ag9610612-2025-00069
- 6 CRANIOFIX ABSORBABL.CLAMP STERILE 11MMApr 29, 2025MalfunctionAesculap Ag9610612-2025-00070
Event type breakdown
Recalls
1 recall events for this product code
Registered firms
87 firms currently registered for this product code
Centerpiece S. De R.l De C.v (sterilization Site)
Tijuana Baja California, MX
Depuy Synthes Sales
Bridgewater, MA, US
Jeil Medical Corporation
Seoul, KR
Midwest Sterilization Corp.
JACKSON, MO, US
Aesculap, Inc.
CENTER VALLEY, PA, US
Stryker Leibinger Gmbh & Co. Kg
FREIBURG Baden-Wurttemberg, DE
Ossaware Biotech Co., Ltd.
Shenkang Hsiang Changhua, TW
Steris Schweiz Ag
Daniken Solothurn, CH
Ionisos
Dagneux Ain, FR
Aesculap Ag
TUTTLINGEN, DONAU Baden-Wurttemberg, DE
Abbott Medical
PLANO, TX, US
Medtronic Engineering And Innovation Center (meic)
Hyderabad Telangana, IN
Ionisos
Tarancon Cuenca, ES
Sterigenics U.s. Llc
MULBERRY, FL, US
Medtronic Neurosurgery
Fort Worth, TX, US
Osteonic Co., Ltd.
Seoul, KR
Kinamed, Inc.
CAMARILLO, CA, US
Sterigenics Radiation Technologies, Llc
San Diego, CA, US
Jabil Inc. (elmira)
Horseheads, NY, US
Synthes (usa) Products Llc
West Chester, PA, US
Microware Precision Co., Ltd.
Taichung, TW
Isomedix Operations, Inc.
Minneapolis, MN, US
510(k) clearances
29 clearances for this product code
- Orthocon, Inc.Mar 16, 2026
K253447 · Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)
- Neos Surgery S.LFeb 16, 2024
K240137 · Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System
- Chendu Medart Medical Scientific Co., Ltd.Nov 21, 2023
K221606 · Absorbable Cranial Flap Fixation System
- Ossaware Biotech Co., Ltd.Jun 3, 2020
K192310 · Flap Fixator, Burr Hole Cover
- Neurovention, LLCMar 13, 2020
K192162 · NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate
- Ossdsign ABOct 12, 2018
K181539 · OSSDSIGN Cranioplug
- St Jude MedicalJul 20, 2018
K181382 · GuardianTM Burr Hole Cover System
- Neos Surgery S.LJun 12, 2016
K160739 · Cranial COVER