Drills, Burrs, Trephines & Accessories (Simple, Powered)
Regulation 882.4310
2510(k)s in 12 months (65 all time)
19recalls in 12 months (258 all time)
203recalls that name a 510(k)
Top companies in HBE
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 24, 2026 | SURGIFY MEDICAL OY Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.U1; drills, burrs, trephines & accessories (simple, powered) Open, Classified |
HBE | K253627 |
| Jun 24, 2026 | SURGIFY MEDICAL OY Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.H1; drills, burrs, trephines & accessories (simple, powered) Open, Classified |
HBE | K250380 |
| Jun 24, 2026 | SURGIFY MEDICAL OY Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered) Open, Classified |
HBE | K253627 |
| Jun 24, 2026 | SURGIFY MEDICAL OY Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.H1; drills, burrs, trephines & accessories (simple, powered) Open, Classified |
HBE | K250380 |
| Jun 24, 2026 | SURGIFY MEDICAL OY Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.U1; drills, burrs, trephines & accessories (simple, powered) Open, Classified |
HBE | K253627 |
| Jun 24, 2026 | SURGIFY MEDICAL OY Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephines & accessories (simple, powered) Open, Classified |
HBE | K250380 |
| Jun 24, 2026 | SURGIFY MEDICAL OY Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.U1; drills, burrs, trephines & accessories (simple, powered) Open, Classified |
HBE | K253627 |
| Jun 24, 2026 | SURGIFY MEDICAL OY Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.H1; drills, burrs, trephines & accessories (simple, powered) Open, Classified |
HBE | K250380 |
| Jun 24, 2026 | SURGIFY MEDICAL OY Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered) Open, Classified |
HBE | K253627 |
| Jun 24, 2026 | SURGIFY MEDICAL OY Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered) Open, Classified |
HBE | K250380 |
| Jun 24, 2026 | SURGIFY MEDICAL OY Surgify Halo, 40 mm, Long, Model/Catalog Number: 40.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered) Open, Classified |
HBE | K253627 |
| Jun 24, 2026 | SURGIFY MEDICAL OY Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.125.NVG.H1; drills, burrs, trephines & accessories (simple, powered) Open, Classified |
HBE | K251433 |
| Jun 24, 2026 | SURGIFY MEDICAL OY Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.U1; drills, burrs, trephines & accessories (simple, powered) Open, Classified |
HBE | K253627 |
| Jun 24, 2026 | SURGIFY MEDICAL OY Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.H1; drills, burrs, trephines & accessories (simple, powered) Open, Classified |
HBE | K251433 |
| Jun 24, 2026 | SURGIFY MEDICAL OY Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered) Open, Classified |
HBE | K253627 |
| Jun 24, 2026 | SURGIFY MEDICAL OY Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered) Open, Classified |
HBE | K251433 |
| Jun 24, 2026 | SURGIFY MEDICAL OY Surgify Halo, 3.0 mm, Long, Model/Catalog Number: 30.125.NVG.U2; drills, burrs, trephines & accessories (simple, powered) Open, Classified |
HBE | K253627 |
| Jun 24, 2026 | SURGIFY MEDICAL OY Surgify Halo, 3.0 mm, Short, Model/Catalog Number: 30.070.NVG.U2; drills, burrs, trephines & accessories (simple, powered) Open, Classified |
HBE | K253627 |
| Jun 24, 2026 | SURGIFY MEDICAL OY Surgify Halo, 3.0 mm, Extendable, Model/Catalog Number: 30.000.SEE.U2; drills, burrs, trephines & accessories (simple, powered) Open, Classified |
HBE | K253627 |
| Aug 27, 2025 | Medtronic Xomed, Inc. IPC Powerease System REF 2300000
UDI-DI:
00613994448705
00643169406834.
The IPC POWEREASE System is indicated for drilling, tapping, and driving
screws and working end attachments during spinal surge Open, Classified |
HBE | K111520 |
| Jul 29, 2025 | Phasor Health, LLC Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35 Open, Classified |
HBE | K161704 |
| Jan 17, 2025 | Stryker Corporation stryker 3.0MM Precision Neuro Match Head, REF 5820-107-530, used to cut bone and bone cement during neurosurgery Open, Classified |
HBE | K143320 |
| Jan 17, 2025 | Stryker Corporation stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during neurosurgery Open, Classified |
HBE | K143320 |
| Jan 17, 2025 | Stryker Corporation The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be used to cut bone and bone cement during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat Open, Classified |
HBE | K143320 |
| Oct 11, 2024 | Stryker Corporation 1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling, reaming,
decorticating, shaping and smoothing of bone, bone cement and teeth in a variety of surgical procedures including but not Open, Classified |
HBE | K143320 |
| Aug 26, 2024 | Stryker Corporation Stryker iBur 3.0mm Precision Match Head, Distal Bend-
intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following med Completed |
HBE | K210377 |
| Aug 26, 2024 | Stryker Corporation Stryker iBur 3.0mm Diamond Match Head, Distal Bend -
intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medic Completed |
HBE | K210377 |
| Aug 26, 2024 | Stryker Corporation Stryker iBur 5.0mm Coarse Diamond Round, Distal Bend
intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following med Completed |
HBE | K210377 |
| Aug 26, 2024 | Stryker Corporation Stryker iBur 4.0mm Coarse Diamond Round, Distal Bend -
intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following med Completed |
HBE | K210377 |
| Aug 26, 2024 | Stryker Corporation Stryker iBur 3.0mm Coarse Diamond Round, Distal Bend -
intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following med Completed |
HBE | K210377 |
| Aug 26, 2024 | Stryker Corporation Stryker iBur 4.0mm Diamond Round, Distal Bend-
intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical app Completed |
HBE | K210377 |
| Aug 26, 2024 | Stryker Corporation Stryker iBur 3.0mm Diamond Round, Distal Bend -
intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical ap Completed |
HBE | K210377 |
| Aug 26, 2024 | Stryker Corporation Stryker iBur 2.0mm Diamond Round, Distal Bend-
intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical app Completed |
HBE | K210377 |
| Aug 26, 2024 | Stryker Corporation Stryker iBur 4.0mm Precision Round, Distal Bend-
intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical a Completed |
HBE | K210377 |
| Aug 26, 2024 | Stryker Corporation Stryker iBur 3.0mm Precision Round, Distal Bend-
Intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical a Completed |
HBE | K210377 |
| Jun 24, 2022 | Stryker Instruments Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures. Open, Classified |
HBE | K143320 |
| Oct 21, 2021 | Medtronic Xomed, Inc. Medtronic Sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following produ Open, Classified |
HBE | K081475 |
| May 2, 2018 | Ad-Tech Medical Instrument Corporation AD-TECH Medical Instrument Corporation Drill Sleeve Guides DSG-6-3-090-2.4N utilizing raw material (RM0677) from the following lots from vendor 00-0001062., AD0021502, AD0021628.
Product Usage:
The d Terminated |
HBE | K170442 |
| Sep 5, 2017 | Aesculap Implant Systems LLC ELAN 4 Blade: ELAN 4 1-RING PIN CUTTER D1.0
ELAN 4 1-RING NEURO CUTTER+ SOFT D1.5
ELAN 4 1-RING NEURO CUTTER+ SOFT D2.0
ELAN 4 1-RING NEURO CUTTER+ SOFT D2.5
ELAN 4 1-RING NEURO CUTTER SOFT D3.0
ELAN Terminated |
HBE | None listed |
| Sep 5, 2017 | Aesculap Implant Systems LLC ELAN 4 Drill: ELAN 4 1-RING TWIST DRILL D1.5
ELAN 4 1-RING TWIST DRILL D2.0
ELAN 4 2-RING TWIST DRILL D1,0/4,0MM
ELAN 4 2-RING TWIST DRILL D1,1/4,0MM
ELAN 4 2-RING TWIST DRILL D1,2/4,0MM
ELAN 4 2-RING Terminated |
HBE | None listed |
| Sep 5, 2017 | Aesculap Implant Systems LLC ELAN 4 Burr: ELAN 4 1-RING ROSEN BURR+ D0.6
ELAN 4 1-RING ROSEN BURR+ D0.8
ELAN 4 1-RING ROSEN BURR D1.0
ELAN 4 1-RING ROSEN BURR TC D1.0
ELAN 4 1-RING ROSENBURR+ D1.0
ELAN 4 1-RING ROSEN BURR D1.4
EL Terminated |
HBE | None listed |
| Dec 21, 2016 | Stryker Instruments Div. of Stryker Corporation 8450-009-040 4.0MM Precision Round, 13CM, single use, Sterile
The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases.
Each cutting acce Terminated |
HBE | None listed |
| Dec 21, 2016 | Stryker Instruments Div. of Stryker Corporation 8450-009-030 3.0MM Precision Round, 13CM, single use, Sterile
The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases.
Each cutting acce Terminated |
HBE | None listed |
| Dec 21, 2016 | Stryker Instruments Div. of Stryker Corporation 8450-010-040 4.0MM Round, 13CM, single use, Sterile
The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases.
Each cutting accessory con Terminated |
HBE | None listed |
| Dec 21, 2016 | Stryker Instruments Div. of Stryker Corporation 8470-009-040 4.0MM Precision Round, 16CM, single use, Sterile
The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases.
Each cutting acce Terminated |
HBE | None listed |
| Dec 21, 2016 | Stryker Instruments Div. of Stryker Corporation 8470-009-030 3.0MM Precision Round, 16CM, single use, Sterile
The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases.
Each cutting acce Terminated |
HBE | None listed |
| Dec 21, 2016 | Stryker Instruments Div. of Stryker Corporation 8450-107-525 2.5MM Precision Match Head, 13CM, single use, Sterile
The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases.
Each cutting Terminated |
HBE | None listed |
| Dec 21, 2016 | Stryker Instruments Div. of Stryker Corporation 8450-107-530 3.0MM Precision Match Head, 13CM, single use, Sterile
The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases.
Each cutting Terminated |
HBE | None listed |
| Oct 6, 2016 | The Anspach Effort, Inc. IMRI SHORT HD ATTACHMENT
Product Usage:
Pneumatic system Terminated |
HBE | K040186 |
| Oct 6, 2016 | The Anspach Effort, Inc. IMRI SHORT ATTACHMENT
Product Usage:
Pneumatic system Terminated |
HBE | K040186 |
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